Enroll in a Study

Chronic Kidney Disease

Abbott
ACQUIRE Study

Study Details

An on-going for a period of approximately five (5) years

Specimen Collection and Usability Study to Support Ongoing Clinical Research.

Patient Information

 Are you willing to donate your biospecimen samples like Blood, Urine, etc.

 Medical device manufacturers must have access to fresh and frozen biospecimens and related data to support ongoing research.

 By donating your biospecimen, you will help researchers to get one step closer to tackle hard to treat diseases.

 Fresh human specimens including blood (venous & fingersticks), urine, nasal/nasopharyngeal, and oral fluid samples may be collected for future research and development.

 If you are interested to participate in this study, sign up today.

Physician Information

Abbott Rapid Diagnostics (ARDx) In-House Specimen Collection and Usability Study to Support Ongoing Quality and Research and Development Activities - ACQUIRE.

 Target population: Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

 The problem: Medical device manufacturers must have access to fresh and frozen biospecimens and related data to support ongoing quality activities such as product release testing, and product support investigations, as well as supporting ongoing research and development, manufacturing and production activities, including but not limited to benchtop analytical studies.

Why problem exist: There is a remarkable need for human samples and data to support Abbott medical device manufacturing needs.

 New approach to solve the problem: Using different locations helps to increase enrollment and identifies specific subject populations whose biospecimens are suitable for future research, development, manufacturing and quality activities.

 Study: ARDx In-House Specimen Collection and Usability Study to Support Ongoing Quality and Research and Development Activities - ACQUIRE.

 Study duration: The study is designed to be on-going for a period of approximately five (5) years to meet the needs of ARDx.

 New intervention: This protocol is designed to meet the ongoing need for human samples and data to support Abbott medical device manufacturing needs. Specimens collected from this study may be tested immediately after collection and/or frozen and stored for future research.

 Study purpose: To collect and/or bank fresh human specimens and usability of data for use in Abbott research like participants’ biometric information, medical history, etc.

 Sponsor Name: Abbott Rapid Diagnostics (ARDx)

Anjii Pharmaceutical
Metformin Hydrochloride Delayed-release

Study Details

52 weeks

A study to Compare the Glycemic Effects, Safety, and Tolerability of Metformin Hydrochloride Delayed-Release Tablets in Patients with Type 2 Diabetes Mellitus with varying renal function from normal up to CKD3B.

Patient Information

 Are you a Patient with chronic kidney disease (CKD) with type 2 Diabetes?

 Diabetes is the most common cause of Chronic Kidney Disease in US.

 Sometimes control of blood sugar level with Metformin gets complicated due to its side effects.

 New Metformin Delayed Release tablets may have the same great effects with much lower side effects.

 If you are interested to participate in this study, sign up today.

Physician Information

A study to Compare the Glycemic Effects, Safety, and Tolerability of Metformin Hydrochloride Delayed-Release Tablets in Patients with Type 2 Diabetes Mellitus with varying renal function from normal up to CKD3B.

 Target population: T2DM patients with normal renal function and varying degrees of CKD not exceeding CKD3B.

 The problem: All currently available forms of metformin (Metformin IR, Metformin XR) have been formulated to optimize absorption in the proximal small intestine, resulting in high plasma exposure.

 Why problem exist: This is dangerous in populations such as chronic kidney disease (CKD) where high plasma metformin exposure can predispose them to rare, but life-threatening, episodes of lactic acidosis.

 New approach to solve the problem: Current emerging evidence indicates that a large part of metformin’s efficacy is mediated by direct exposure to the distal small intestine lumen without the need for high systemic exposure. Therefore, a novel formulation optimized for high distal small intestine exposure, but low systemic exposure, may considerably improve metformin’s benefit-to-risk ratio specifically in CKD patients.

 Study: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo- and Comparator-Controlled Study to Compare the Glycemic Effects, Safety, and Tolerability of Metformin Hydrochloride Delayed-Release Tablets in Patients with Type 2 Diabetes Mellitus with varying renal function from normal up to CKD3B.

 Study duration: 52 weeks

 New intervention: Metformin hydrochloride Delayed Release tablets (Metformin DR) were formulated to bypass the proximal small intestine, and trigger drug dissolution and absorption in the distal small intestine. The results of the preliminary short-term clinical studies indicate that Metformin DR administration results in substantially reduced systemic exposure to metformin relative to currently approved metformin-containing products yet maintains comparable efficacy in lowering blood glucose and enhancing gut-hormone release in T2DM patients.

 Study purpose: The primary purpose of this Phase 3 clinical study is to collect pivotal data confirming the safety and efficacy of Metformin DR in T2DM patients with varying renal function from normal up to CKD3B.

 Sponsor Name: Anji Pharma (US) LLC

AstraZeneca Zenith Study
Zibotentan and Dapagliflozin

Study Details

17-19 months

Dapagliflozin with Zibotentan may reduce chronic kidney disease progression.

Patient Information

 Are you a Patient with chronic kidney disease (CKD)?

 CKD often progresses slowly and mostly asymptomatically until kidney failure occurs.

Administration of kidney protective agents will reduce the progression rate of CKD.

 New intervention: Co-administration of Dapagliflozin with Zibotentan is expected to lessen CKD progression in an additive manner.

 If you are interested to participate in this study, sign up today.

Physician Information

A Phase 2b multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2.

 Target population: Patients with CKD with eGFR between 20 and 60 mL/min/1.73 m2.

 The problem: CKD often progresses slowly and mostly asymptomatically until kidney failure occurs. Endothelin-1 A (ETA) receptor antagonists have shown efficacy for urine albumin to creatinine ratio reduction in patients with CKD.

Why problem exist: Un-locking the potential of ETA receptor antagonists in the treatment of CKD requires mitigation of their potential sodium and fluid retention risk.

 New approach to solve the problem: Co-administration of a diuretic agent, potentially with renal protective effect would alleviate the sodium and fluid retention effect of ETA antagonist.

 Study: A Phase 2b multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2.

 Study duration: 17-19 months

 New intervention: o-administration of dapagliflozin with zibotentan is expected to mitigate zibotentan’s potential sodium and fluid retention due to the intrinsic diuretic and natriuretic effects of SGLT2 inhibition. The combination of zibotentan and dapagliflozin for treatment of CKD is expected to be additive, since their mechanisms of action are different.

 Study purpose: To evaluate the effect, dose-response relationship, and safety and tolerability of zibotentan and dapagliflozin alone and in combination versus placebo on UACR changes and/or blood pressure in CKD patients, with special focus on hypotension and hospitalizations due to HF.

 Sponsor Name: AstraZeneca, Inc.

AZ - NEUTRALIZE - SZC

 

Study Details

28 days

SZC may be beneficial in controlling high serum potassium and low bicarbonate level in CKD patients.

Patient Information

 Are you a CKD patient with high serum potassium and low bicarbonate level?

 Low serum bicarbonate and high potassium level increases mortality in CKD patients.

Current treatment with sodium bicarbonate is limited by high pill burden needed to correct the serum bicarbonate.

 New intervention: SZC treats hyperkalemia and causes an increase in serum bicarbonate at the same time.

 If you are interested to participate in this study, sign up today.

Physician Information
A prospective, randomized, double-blind, placebo-controlled, parallel, multicenter, Phase 3b study to investigate the safety and efficacy of Sodium Zirconium Cyclosilicate (SZC) in patients with hyperkalemia and low bicarbonate.

 Target population: CKD patients with hyperkalemia and low bicarbonate serum level.

 The problem: Metabolic acidosis associated with CKD occurs in about 1 in 3 patients with CKD stage 3-5 with hyperkalemia. low serum bicarbonate and associated metabolic acidosis have been associated with an increased risk for CKD progression, metabolic bone disease, and mortality in CKD patients.

 Why problem exist: Current treatment with sodium bicarbonate is limited by high pill burden needed to correct the serum bicarbonate. Furthermore, a proportion of CKD patients have a negative acid balance despite having normal serum bicarbonate levels. Therefore, the optimal serum bicarbonate level in CKD remains to be determined

 New approach to solve the problem: Given the evidence that SZC treats hyperkalemia and causes a dose-dependent increase in serum bicarbonate, patients with both these electrolyte/acid-base complications may observe efficacy from treatment with SZC.

 Study: A Double-blind Randomized Placebo-controlled Parallel Design Multicenter Phase IIIb Study of the Effect of Sodium Zirconium Cyclosilicate (SZC) on Serum Potassium and Serum Bicarbonate in Patients with Hyperkalemia and Metabolic Acidosis Associated with Chronic Kidney Disease.

 Study duration: 28 days

 New intervention: Preliminary data suggest, SZC may be able to rapidly correct hyperkalemia and maintain normokalemia irrespective of underlying morbidity, and its favorable safety profile, have been well documented in the clinical program. SZC treatment has also been associated with dose-dependent increases in serum bicarbonate based on previous Phase II, open-label Phase III studies.

 Study purpose: To evaluate the efficacy of SZC as compared to placebo in maintaining normal/normalizing serum K+ and increasing serum bicarbonate in patients with hyperkalemia and metabolic acidosis associated with CKD.

 Sponsor Name: Akebia Therapeutics, Inc

AZ Flair - AZD5718

 

Study Details

~28 weeks

AZD5718 may reduce protein in urine in patients with Chronic Kidney Disease.

Patient Information

 Are you a Patient with chronic kidney disease (CKD) who excrete protein in urine?

 CKD often progresses slowly and mostly asymptomatically until kidney failure occurs.

 Administration of kidney protective agents will reduce the progression rate of CKD

 New intervention: AZD5718 may reduce protein excretion through urine and slow down the progression of your kidney disease.

 If you are interested to participate in this study, sign up today.

Physician Information
A Phase 2b, randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to evaluate the efficacy, safety and pharmacokinetic of AZD5718 in participants with proteinuric CKD.

 Target population: Patients with proteinuric chronic kidney disease.

 The problem: Five-lipoxygenase activating protein (FLAP) is part of the 5-LO pathway that generates biologically active lipid mediators, leukotrienes. Leukotrienes have been implicated in the etiology of CKD both through pro-inflammatory and vascular mechanisms.

Why problem exist: Leukotriene B4 and LTC/LTD4 can cause endothelial dysfunction, increasing glomerular permeability to albumin. Leukotriene C4 and LTD4 are also vasoconstrictive reducing renal perfusion. It is hypothesized that leukotrienes maybe partially responsible for CKD progression.

 New approach to solve the problem: Inhibition of
FLAP activity will attenuate production of pro-inflammatory and vasoactive leukotrienes and may reduce albuminuria and eventually CKD progression. Adding FLAP inhibitors to other reno-protective agents like SGLT-2 inhibitors may enhance their effect as well.

 Study: Dose-Response Effect, Efficacy, and Safety of AZD5718 in Reducing Albuminuria in Participants with Proteinuric Chronic Kidney Disease.

 Study duration: 20 weeks

 New intervention: ZD5718, previously identified as AZ13702997, is a reversible FLAP inhibitor. Inhibition of FLAP activity will attenuate production of pro-inflammatory and vasoactive leukotrienes by leukocytes (eg, neutrophils) and is hypothesised to reduce albuminuria in the CKD population with and without DM.

 Study purpose: To assess renal function improvement, as defined by change in urine albumin excretion. Additionally, the dose-response relationship, and the safety profile of AZD5718 will be evaluated. Furthermore, the additive effect of the SGLT2i dapagliflozin taken together with AZD5718 on albuminuria will be assessed.

 Sponsor Name: AstraZeneca, Inc.

Bayer 21177 Study
Finerenone

Study Details

32-49 months

Finerenone may reduce the decline rate of kidney function in non-diabetic patients with chronic kidney disease.

Patient Information

 Are you a non-diabetic Patient with chronic kidney disease?

 CKD often progresses slowly and mostly asymptomatically until kidney failure occurs.

 FDA has already approved Finerenone tablets to reduce the risk of kidney function decline and to prevent kidney failure in adults with chronic kidney disease associated with type 2 diabetes.

 New intervention: n this study, Bayer is investigating Finerenone usage in non-diabetic population.

 If you are interested to participate in this study, sign up today.

Physician Information

A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (CKD).

 Target population: Patients with non-diabetic CKD of different disease etiology at risk of progressive renal function decline.

 The problem: CKD often progresses slowly and mostly asymptomatically until kidney failure occurs.

 Why problem exist: ACEI and ARB are considered standard of care for patients with nondiabetic CKD and albuminuria. How ever, existing evidence is mainly based on efficacy seen in diabetic patients and comparable small numbers of non-diabetic patients were studied.

 New approach to solve the problem: FDA has approved finerenone tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

 Study: A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease.

 Study duration: 32-49 months

 New intervention: Recently completed studies showed the benefit of SGLT2 in CKD patients with and without diabetes. Finerenone is already studied in more than 13,000 patients with CKD with Type 2 diabetes. In this study, Bayer is investigating Finerenone usage in non-diabetic population.

 Study purpose: To demonstrate that finerenone in addition to Standard of Care, is superior to placebo in delaying the progression of kidney disease. Also, to assess efficacy and safety of finerenone (10 mg and 20 mg, OD) compared to placebo in participants with non-diabetic chronic kidney disease.

 Sponsor Name: Bayer, Inc.

CinCore Study

 

Study Details

20 weeks

A new medication, CIN-107, with potential to control high blood pressure in patients with Chronic Kidney Disease (CKD).

Patient Information

 Are you a patient with Chronic Kidney Disease (CKD) and uncontrolled high blood pressure?

 Inappropriately high levels of aldosterone, a hormone, in patients with chronic kidney disease (CKD) have been suggested to contribute to CKD-associated high blood pressure, kidney injury, and excreting protein in urine, proteinuria.

 Unfortunately, selectively inhibiting aldosterone without affecting the synthesis of cortisol is difficult. Inhibiting cortisol leads to impair immunological responses, and some metabolic disorders.

 New intervention: This new medication, CIN-107, has a potent anti-aldosterone effects without suppressing cortisol. It may help to control high blood pressure in patients with CKD and uncontrolled high blood pressure.

 If you are interested to participate in this study, sign up today.

Physician Information
A Randomized, phase 2, Double-Blind, Placebo-Controlled Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease (CKD).

 Target population: Patients with proteinuric chronic kidney disease.

 The problem: Inappropriately high levels of aldosterone in patients with chronic kidney disease (CKD) have been suggested to contribute to CKD-associated hypertension by promoting inflammation, oxidative stress, fibrosis, mesangial cell proliferation, and podocyte injury, and proteinuria.

Why problem exist: One of the challenges that has impacted the development of aldosterone synthase inhibitors (ASIs) has been the difficulty in selectively inhibiting aldosterone synthase without affecting the synthesis of cortisol. Undesired cortisol inhibition compromises stress and immunologic responses, and has adverse effects on some metabolic functions, and possibly increased mortality rates.

 New approach to solve the problem: The selective blockade of aldosterone without suppression of cortisol pathway represents a potential means to reduce blood pressure as well as to mitigate kidney damage in patient with CKD.

 Study: A Randomized, phase 2, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease.

 Study duration: ~ 28 weeks

 New intervention: CIN-107 is a highly potent, selective, and competitive inhibitor of human aldosterone synthase. In preclinical in-vivo studies (primarily conducted in primates), CIN-107 significantly lowered aldosterone level in a dose-dependent manner without affecting cortisol levels. CIN-107 in healthy male volunteers demonstrated that single oral doses of CIN-107 up to 360 mg were well tolerated. There were no deaths, serious adverse events (SAEs), or dose-limiting events. Single doses of CIN-107 reduced plasma and urine aldosterone levels by approximately 85% to 90% in a dose-dependent manner.

 Study purpose: The primary objective of the study is to evaluate the treatment effect of CIN-107 on systolic blood pressure (SBP) compared to placebo in patients with uncontrolled hypertension and CKD.

 Sponsor Name: CinCor Pharma, Inc.

Falcon Study

 

Study Details

3-5 years

A new medication, Bardoxolone Methyl, with potential to delay kidney failure in patients with Autosomal Poly-Cystic Kidney Disease (APCKD).

Patient Information

 Are you a patient with Autosomal Dominant Polycystic Kidney Disease (ADPKD)?

 Autosomal dominant polycystic kidney disease (ADPKD) is a multi-organ disorder and the leading inheritable cause of kidney failure.

 Unfortunately, despite available therapies, patients with ADPKD have progressively declining kidney function.

 New intervention:  This new medication, Bardoxolone Methyl, has anti-inflammatory and tissue-protective effects. It may protect your kidney from kidney failure.

 If you are interested to participate in this study, sign up today.

Physician Information
A multi-center Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease (PCKD).

 Target population: Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

 The problem: Autosomal dominant polycystic kidney disease (ADPKD) is a multi-organ disorder, and the leading inheritable cause of kidney failure.

 Why problem exist: Renal cyst formation and growth in ADPKD triggers a cascade of pathological inflammatory processes that, over prolonged periods, result in oxidative stress, mesangial matrix expansion, glomerulosclerosis and fibrosis, decreased surface area for filtration, and reduced kidney function. Thus, the pathogenic role of inflammatory processes in ADPKD disease progression and declining renal function is similar to that of other forms of chronic kidney disease.

 New approach to solve the problem: Despite available therapies, patients with ADPKD have progressively declining kidney function, with average estimated glomerular filtration rate (eGFR) declines of 2.8 to 3.8 mL/min/1.73m2 per year. Sustaining or improving eGFR and inhibition of activated inflammatory and pro-fibrotic pathways could be a potential way to reduce inflammation, improve renal function, and prevent injury, remodeling, and fibrosis in many animal models of renal injury and disease.

 Study: A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease

 Study duration: 3-5 years

 New intervention: Bardoxolone methyl activates molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting ROS-mediated pro-inflammatory signaling though binding to Keap1 and activation of Nrf2, a transcription factor that increases cellular antioxidant and detoxification enzymes and promotes normal mitochondrial function. These anti-inflammatory and tissue-protective effects of bardoxolone methyl suppress multiple cellular processes that conspire to promote GFR loss in ADPKD.

 Study purpose: To collect exploratory data on the efficiency and safety of Bardoxolone methyl in patients with ADPCKD.

 Sponsor Name: Reata Pharmaceuticals, Inc.

USRC Kidney Research
Frontier Study

Study Details

9 months followed by an additional 30-day safety follow-up period
Patient Information

 Are you a patient with anemia due to Chronic kidney disease?

 Severity of your anemia is directly related to the occurrence of heart attack and stroke. It may also accelerate the progression of your CKD

 The goal of using ferric citrate (Iron salt) therapy is to avoid iron storage depletion.

 New intervention: Ferric citrate (Iron salt) may delay the progression of advanced CKD to kidney failure requiring maintenance dialysis or death.

 If you are interested to participate in this study, sign up today.

Physician Information

Ferric Citrate for the Prevention of Renal Failure in Adults with Advanced Chronic Kidney Disease (FRONTIER)

 Target population: Adult subjects ≥18 years old with a diagnosis of non-dialysis dependent (NDD) advanced chronic kidney disease (CKD).

 The problem: The long-term safety of IV iron administration has also not been established, and there are concerns that patients may be exposed to increased oxidative stress and greater vulnerability to infections. erythropoiesis-stimulating agent (ESAs) are another treatment modality for anemia of CKD that are widely used in dialysis dependent-CKD patients but safety concerns due to excess cardiovascular risk for ESAs resulted in black box warnings in 2007.

Why problem exist: Oral iron is preferred in patients with NDD-CKD for its convenience and low cost. However, the tolerability and efficacy of currently available oral iron formulations is often limited by gastrointestinal (GI) side effects, poor adherence to therapy, and poor absorption.

 New approach to solve the problem: The goals of early iron therapy (ferric citrate) are to avoid iron storage depletion, to prevent impairment of erythropoiesis due to iron deficiency, and to help achieve and maintain target Hb levels. This has a potential benefits of avoiding or minimizing blood transfusions, (ESA) therapy, and anemia-related symptoms.

 Study: Multicenter, randomized, double-blind, placebo-controlled clinical trial to determine the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality in patients with non-dialysis dependent.

 Study duration: Subjects will remain on study drug for up to 9 months followed by an additional 30-day safety follow-up period.

 New intervention: pilot randomized trial of ferric citrate compared to standard of care in patient with advanced CKD showed that subjects treated with ferric citrate demonstrated significant changes in laboratory values associated with improvements in anemia and iron. Additionally, this study demonstrated a clinically significant reduction in the risk of the composite endpoint of death, dialysis, or transplantation in patients randomized to ferric citrate.

 Study purpose: To determine the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality compared to placebo in adult patients with advanced CKD.

 Sponsor Name: Akebia Therapeutics, Inc. USRC Kidney Research
PI(s): Dr. Berenji, Dr. boiskin, Dr. Fadda, Dr. Meyer

Otsuka
Vadadustat Study

Study Details

~ 64 weeks
Patient Information

 Are you a patient on hemodialysis who requires erythropoiesis-stimulating agent (ESA) treatment for treatment of anemia?

 The risks associated with ESAs, including an increased risk of death and stroke, highlight the need for additional therapies.

 Developing an orally active therapeutic agent for the treatment of anemia in CKD patients might minimize or avoid these risks when compared to currently available treatment.

 New intervention:  In preliminary studies, Vadadustat showed to be an effective agent to treat anemia in CKD patients with acceptable safety profile.

 If you are interested to participate in this study, sign up today.

Physician Information

Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting from Erythropoiesis-stimulating Agents (ESAs).

 Target population: Patients ≥ 18 years of age receiving chronic, outpatient in-center hemodialysis TIW, with pre-specified Hb values, on maintenance treatment with an ESA.

 The problem: As CKD progresses, the combined effect of decreased RBC production from lower erythropoietin (EPO) signaling, increased RBC destruction, and reduced iron availability to the bone marrow results in the increased prevalence and severity of anemia.

 Why problem exist: The risks associated with erythropoiesis-stimulating agents (ESAs), including an increased risk of death and CV events highlight the need for additional therapies that might minimize or avoid these risks when compared to currently available recombinant protein-based ESAs. Therefore, the unmet medical need for the treatment of anemia in dialysis-dependent CKD (DD-CKD) patients remains high.

 New approach to solve the problem: Vadadustat is a synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases (HIF-PHs) for the treatment of anemia associated with CKD.

 Study: This is a Phase 3b, randomized, open-label, sponsor-blind, active-controlled trial of vadadustat
versus darbepoetin alfa for the maintenance treatment of anemia in hemodialysis subjects, after conversion from Erythropoiesis-stimulating Agents (ESA) therapy.

 Study duration: Individual subjects will participate in total trial duration of approximately 64 weeks.

 New intervention: Vadadustat showed dose-dependent increases in erythropoietin (EPO) concentrations in Phase 1 and Phase 2 studies. The changes in EPO have been accompanied by an increase in reticulocytes and Hb as well as increases in total iron binding capacity (TIBC) and decreases in hepcidin and ferritin. Overall, the safety profile for vadadustat has been acceptable

 Study purpose: The primary objective of the trial is to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis subjects.

 Sponsor Name: Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC)
PI(s): Dr. Meyer

Novartis - APPLAUSE Study

 

Study Details

20 weeks
Patient Information

 Are you a patient with IgA nephropathy?

 IgA nephropathy may progress slowly but persistently to end-stage renal disease (ESRD) within 10-15 years.

 There are no evidence-based disease-modifying treatment for IgA nephropathy.

 New intervention: NP023 is a first-in-class, inhibitor of Complement factor B (FB) and may have a potential to reduce protein in urine and may delay the progression of the IgA nephropathy.

 If you are interested to participate in this study, sign up today.

Physician Information
A Randomized, phase 2, Double-Blind, Placebo-Controlled Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease (CKD).

 Target population: Patients with proteinuric chronic kidney disease.

 The problem: Inappropriately high levels of aldosterone in patients with chronic kidney disease (CKD) have been suggested to contribute to CKD-associated hypertension by promoting inflammation, oxidative stress, fibrosis, mesangial cell proliferation, and podocyte injury, and proteinuria.

Why problem exist: One of the challenges that has impacted the development of aldosterone synthase inhibitors (ASIs) has been the difficulty in selectively inhibiting aldosterone synthase without affecting the synthesis of cortisol. Undesired cortisol inhibition compromises stress and immunologic responses, and has adverse effects on some metabolic functions, and possibly increased mortality rates.

 New approach to solve the problem: The selective blockade of aldosterone without suppression of cortisol pathway represents a potential means to reduce blood pressure as well as to mitigate kidney damage in patient with CKD.

 Study: A Randomized, phase 2, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease.

 Study duration: ~ 28 weeks

 New intervention: CIN-107 is a highly potent, selective, and competitive inhibitor of human aldosterone synthase. In preclinical in-vivo studies (primarily conducted in primates), CIN-107 significantly lowered aldosterone level in a dose-dependent manner without affecting cortisol levels. CIN-107 in healthy male volunteers demonstrated that single oral doses of CIN-107 up to 360 mg were well tolerated. There were no deaths, serious adverse events (SAEs), or dose-limiting events. Single doses of CIN-107 reduced plasma and urine aldosterone levels by approximately 85% to 90% in a dose-dependent manner.

 Study purpose: The primary objective of the study is to evaluate the treatment effect of CIN-107 on systolic blood pressure (SBP) compared to placebo in patients with uncontrolled hypertension and CKD.

 Sponsor Name: CinCor Pharma, Inc.

NOVO-NORDISK
FLOW study

Study Details

3-5 years

Patient Information
 Are you a patient with Diabetes type-2 (T2D) and Chronic Kidney Disease (CKD)?

 Majority of cases the kidney damage and/or reduced kidney function is caused directly by longstanding and poorly controlled Diabetes.

Up to 70% of the patients with T2D and CKD experience continued deterioration of the kidney function despite using current recommended treatments.

 New intervention:  Treatment with once weekly Semaglutide may have a potential to delay the progression of renal impairment and lower the risk of renal and cardiovascular mortality in patients with T2D and CKD.

 If you are interested to participate in this study, sign up today.

Physician Information

Effect of Semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease – FLOW study.

 Target population: Patients with type 2 diabetes and pre-existing moderate Chronic kidney disease and increased Urine Albumin to Creatinine Ratio.

 The problem: Up to 70% of the patients with T2D and CKD experience continued deterioration of the kidney function despite RAAS blocker treatment. But still there is a major unmet medical need to improve the treatment of CKD in patients with T2D.

 Why problem exist: Improved glycemic control has been suggested to reduce the development and progression of CKD in T2D and it is one of the key recommendation in international treatment guidelines for CKD in T2D patients. A possible reno-protective effect in patients with T2D, CKD and high cardiovascular (CV) risk have been shown with sodium glucose cotransporter-2 (SGLT-2) inhibitors.

 New approach to solve the problem: Recently conducted clinical trials with the glucagon-like peptide-1 (GLP-1) receptor agonists have suggested a possible reno-protective effect in patients with T2D, CKD and high cardiovascular (CV) risk like SGLT-2 inhibitors.

 Study: This is a multi-center, international, randomized, double-blind, parallel-group, placebo-controlled trial comparing Semaglutide 1.0 mg versus placebo both administered s.c. once weekly and added to standard-of-care.

 Study duration: Up to 60 months or more including 3 weeks of screening and up to 5 weeks of follow up. Trial duration for each subject is expected to be approximately 3 to 5 years.

 New intervention: Semaglutide S.C. was approved in the US in 2017 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) under the trade name Ozempic®. Semaglutide is a potent human GLP-1 analogue that acts as a GLP-1 receptor agonist (RA), with a longer half-life (approximately 1 week) suitable for once weekly dosing. Semaglutide improves glycaemic control and has a potential to promote weight loss in subjects with type 2 diabetes (T2D) and also reduce cardiovascular (CV) risk in subjects with T2D at high CV risk.

 Study purpose: To demonstrate that Semaglutide delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality compared to placebo.

 Sponsor Name: Novo Nordisk
PI(s): Dr. Horeish

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If you have questions about Balboa Research,
please complete the contact form or call
George Nilsson, Clinical Research Director.

George Nilsson

Clinical Research Director
(858) 810-8072

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