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End-Stage Renal Disease & Dialysis

Akebia - Vadadustat

 

Study Details

Up to 64 weeks

Vadadustat may be an effective and safe agent to treat anemia in CKD patients.

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: 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

A Randomized Study Evaluating the Efficacy and Safety of Dose Conversion from a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Oral Vadadustat for the Treatment of Anemia.

 Target population: Patients receiving chronic hemodialysis who require erythropoiesis-stimulating agent (ESA) treatment and are on maintenance treatment currently receiving Mircera.

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

 Why problem exist: Anemia associated with CKD has been treated with ESAs, blood transfusions, and iron supplementation. The risks associated with ESAs, including an increased risk of death and CV events, highlight the need for additional therapies.

 New approach to solve the problem: To fulfill this unmet need, the vadadustat clinical program is focused on developing an orally active therapeutic agent for the treatment of anemia in patients with CKD.

 Study: A Randomized, phase 3b, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion from a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects.

 Up to 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 study is to demonstrate the efficacy and safety of vadadustat compared to long-acting ESA (Mircera) for the maintenance treatment of anemia in hemodialysis subjects.

 Sponsor Name: Akebia Therapeutics, Inc

Bayer 20115 Study
Osocimab

Study Details

18 months

Osocimab is a potent anti-clot medication with a lower bleeding risk.

Patient Information

 Are you a Patient with end-stage kidney disease on hemodialysis?

 Patients with ESRD have very high cardiovascular mortality rates. Due to this, most patients are on blood thinner.

Current usage of blood thinner in ESRD patients is associated with a variable unexpected bleeding risk.

 New intervention: Osocimab is a fully human IgG1 antibody that has a profound anti-clot effect, both in arterial and in venous models.

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

Physician Information
A phase 2b randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of Osocimab to ESRD patients on regular hemodialysis.

 Target population: Stable end-stage-renal disease patients requiring hemodialysis (including hemodiafiltration) sessions for approx. 3 times per week.

 The problem: It is well known that patients with ESRD have very high cardiovascular morbidity and mortality rates. ESRD itself is seen as a risk factor for peripheral artery disease (PAD) and Atherothrombosis/ atherosclerosis.

 Why problem exist: Due to increased risk of thromboembolic and bleeding events, treatment options must be carefully evaluated against their benefits and risks in ESRD patients. In the non-ESRD population, current anticoagulation therapies have been shown to be efficacious, however, in ESRD patients, their use is associated with a variable bleeding risk.

 New approach to solve the problem: Inhibiting Factor XI (FXI) is a new target for anticoagulants that have the potential to be associated with a lower risk of bleeding events than currently available anticoagulants. Observational studies in patients with congenital factor XI deficiency suggested that these patients are at reduced risk of ischemic stroke, myocardial infarction, and venous thromboembolism (VTE) compared with those with normal factor XI levels.

 Study: A phase 2b randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of Osocimab to ESRD patients on regular hemodialysis.

 Study duration: 18 months

 New intervention: Osocimab is a fully human monoclonal IgG1 antibody that binds and inhibits activated factor XIa (FXIa). Preclinical pharmacology experiments indicated a profound antithrombotic effect, both in arterial and in venous thrombosis models, in the absence of significantly prolonged bleeding times or increased blood loss.

 Study purpose: This Phase 2b trial will assess the safety and characterize the pharmacokinetic/pharmacodynamic (PK/PD) profile of two different dose cohorts of Osocimab given subcutaneously once a month to participants with ESRD.

 Sponsor Name: Bayer AG, Inc.

Impedimed

 

Study Details

Until recruitment of 70 patients.

A new device which may potentially measures different body fluids in patients who need hemodialysis.

Patient Information

 Are you a patient with End Stage Kidney disease who is on hemodialysis?

 The most common tool for assessing how much fluid should be removed during a dialysis session is “dry weight”. Dry weight is calculated by examining and weighing the patient to ascertain how much fluid they have gained between dialysis sessions.

Complications can occur if too much fluid is removed or if the fluid is removed too quickly.

 Accurate measurement of volume status is essential for effective dialysis. SOZO, a bioimpedance spectroscopy (BIS) method is a non-invasive method to assess body water. SOZO improves discrimination of volume overload from Heart failure as a cause of dyspnea in patients presenting to the emergency department, and is sensitive to changes in both pulmonary and peripheral edema.

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

Physician Information

An observational Study of Bioimpedance Spectroscopy (BIS) for Use in a patient on hemodialysis.

 Target population: atients with End Stage Renal Disease (ESRD) who are on hemodialysis.

 The problem: Accurate measurement of patient’s volume status is essential for effective dialysis. The risk of complications due to hemodialysis will be higher if not enough fluid is removed. This often results in patients being left in a state of chronic subclinical fluid overload.

Why problem exist: The most common tool for assessing how much fluid should be removed during a dialysis session is “estimated dry weight (EDW)”. While using EDW is quick, non-invasive, and easy to perform, but it is likely insensitive and may not provide accurate indication of a patient’s true fluid volume status.

 New approach to solve the problem: By using a bioimpedance spectroscopy (BIS) device, we may be able to estimate the following body composition parameters: Total Body Water (TBW), Intracellular Fluid (ICF), and Extracellular Fluid (ECF). The device may also enable us to monitor patient’s volume status and provides reports to support clinical and research practices.

 Study: In this prospective observational study, the correlation between changes in patient’s fluid volume status and symptoms will be assessed. Changes in BIS parameters may correlate with changes in fluid volume and patient’s symptoms; thus, This may provide a noninvasive but accurate measurement of volume status in ESRD patients on dialysis.

 Study duration: Until recruitment of 70 patients.

 New intervention: The SOZO device is a BIS device that has been cleared by the US Food and Drug Administration (FDA) for use in several clinical settings including monitoring fluid in patients living with heart failure. SOZO parameters will identify patients with hypervolemia and may be used to estimate accurately the amount of fluid required to be removed from the patient during a hemodialysis session.

 Study purpose: To estimate the accurate amount of fluid required to be removed from the patient during a hemodialysis session.

 Sponsor Name: ImpediMed Limited

Merck
MK-2060

Study Details

Almost a year.

A new potential treatment to prevent or delay Arterio-Venous Graft clotting in patients with End Stage Kidney Disease on hemodialysis.
Patient Information

 Are you a patient with Arterio-Venous Graft (AVG) on hemodialysis?

 The chance that your AV Graft gets clotted in a year is more than 50%.

Current treatments are not tackling the problem enough and there are some side effects.

  There is a new treatment that may prevent or delay your AV graft clotting.

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

Physician Information
A new potential treatment to prevent or delay Arterio-Venous Graft clotting.

 Target population: Patients with ESRD receiving hemodialysis via an arteriovenous graft (AVG).

 The problem: Annual rates of AVG failure from thrombosis of >50% [Miller, P. E., et al 2000].

 Why problem exist: Anticoagulants is met with the challenges that these patients have an increased risk of clinically important bleeding due to uremia-related platelet dysfunction and uncertainty in dose adjustment of anticoagulants in ESRD patients. Warfarin is also generally avoided in ESRD due to its complex management and risk of bleeding in this setting. Direct Oral Anti-Coagulants (DOACs) such as Factor Xa inhibitors are not included in guideline recommendations for ESRD due to their reliance on renal clearance and a lack of clinical data.

 New approach to solve the problem: Targeting activity of Factor XI is a novel approach in anticoagulation. Factor XI is a key component in the intrinsic pathway, activated by circulating thrombin, which in turn leads to greater thrombin production and amplification of clot formation. Congenital loss of activity of Factor XI (hemophilia C) leads to reduction in lifetime risk of thrombosis and cardiovascular events but is associated with only minimal disruption of hemostasis [Preis M, Hirsch J, Kotler A, Zoabi A, Stein N, Rennert G, et al. 2017]. Pharmacologic efforts to suppress Factor XI production or activity, for example using anti-sense oligonucleotides or mAb, have demonstrated successful reduction of clot formation with minimal bleeding effects and suggest Factor XI is a highly desirable pharmacological target [Weitz, et al 2020].

 Study: This Study (MK-2060-004) is a double-blind, randomized, placebo-controlled, multiple site, sequential panel study to evaluate the safety, tolerability, PK, and PD of single (Part 1) and multiple (Part 2) doses of IV administration of MK-2060 in older adult participants (age ≥40 and ≤80; men and WONCBP) with ESRD on hemodialysis.

 Study duration: Almost a year.

 New intervention: MK-2060 (SC or IV) is a human anti-Factor XI mAb that inhibits Factor XI activation of Factor XIa. Targeting Factor XI inhibition with MK-2060 may achieve effective anticoagulation for ESRD patients without a prohibitive increase in bleeding events.

 Study purpose: Does AVG get clotted at all? How long does it take to get clotted? Compare the time AVG gets clotted in target population to patients not taking MK-2060 (placebo group).

 Sponsor Name: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NephroNet
ADAPT Study

Study Details

~25 weeks
Patient Information

 Are you a patient on hemodialysis?

 Atrial fibrillation is the most common form of post-dialysis heart arrhythmia which can be observed in over 40% of dialysis patients for up to 12 hours after dialysis.

The current standard dialysate may contribute to patient heart arrythmias.

 New intervention: Using the potassium binder, sodium zirconium cyclosilicate (Lokelma) may reduce the rate of post-dialysis atrial fibrillation

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

Physician Information

A Prospective, Randomized, Multi-Center, Open-Label, Cross-Over Study of Sodium Zirconium Cyclosilicate to Control Interdialytic Hyperkalemia Following Augmentation of Dialysate Potassium: Efficacy to Reduce the Incidence of Post-Dialysis Atrial Fibrillation and Clinically Significant Cardiac Arrhythmias - ADAPT Trial.

 Target population: Patients with end stage renal disease (ESRD) receiving routine out-patient dialysis using a standard 2.0 potassium ion (K+)/2.5 calcium ion (Ca++) dialysate bath.

 The problem: Annualized death rates for all ESRD patients is approximately 23.7% with cardiac disease accounting for 40% of that number. The cause of death is not completely due to atherosclerotic disease or myocardial infarction, but rather due to cardiac arrhythmias and sudden death. Atrial fibrillation is the most common form of post-dialysis arrhythmia which can be observed in over 40% of dialysis patients for up to 12 hours after dialysis.

Why problem exist: Dialysis itself may directly contribute to the development of dysrhythmias presumably through the need to clear excess volume and electrolytes. The standard practice dialyzing patients with 2.0 mEq/L K+ dialysate has been shown to slow atrial conduction rates and contribute to patient mortality.

 New approach to solve the problem: Concomitant usage of higher potassium bath with oral treatment of interdialytic hyperkalemia will reduce the incidence and duration of post-dialysis atrial fibrillation.

 Study: A Prospective, Randomized, Multi-Center, Open-Label, Cross-Over Study of Sodium Zirconium Cyclosilicate to Control Interdialytic Hyperkalemia Following Augmentation of Dialysate Potassium: Efficacy to Reduce the Incidence of Post-Dialysis Atrial Fibrillation and Clinically Significant Cardiac Arrhythmias.

 Study duration: Study will be approximately 25 weeks.

 New intervention: Preliminary data suggest that that the use of a 3.0 mEq/L K+ dialysate with the addition of potassium binder sodium zirconium cyclosilicate (Lokelma) to control interdialytic hyperkalemia will reduce the rates of post-dialysis atrial fibrillation compared to dialysis with a standard 2.0 mEq/L K+ dialysate.

 Study purpose: To demonstrate whether increasing the K+ concentration in a standard hemodialysis bath from 2.0 K+/2.5 Ca++ to a 3.0 K+/2.5 Ca++ composition with SZC will reduce the incidence of atrial fibrillation events.

 Sponsor Name: NephroNet Inc.
PI(s): Dr. Meyer

NephroSynergy - Rediscovery Life
Sciences - Suramin Study

Study Details

Total study duration is expected to be approximately 6 months; and a follow-up period of approximately 25 weeks.
Patient Information

 Are you a patient with Acute Kidney Injury irresponsive to current medical and supportive treatment?

 AKI is a serious condition and current treatment is mainly supportive.

There are no Food and Drug Administration (FDA)-approved treatments for AKI, thus it is a serious medical condition for which there are no effective drug therapies.

 New intervention: Rediscovery Life Sciences proposes that suramin’s unique mechanism of action could make it an important new drug candidate for the treatment of Acute Kidney Injury in those patients with significant renal injury.

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

Physician Information

A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects with Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI.

 Target population: Patients with Acute Kidney Injury stage I, II, or III defined by increase of creatinine campared to baseline and prespecified urine output.

 The problem: AKI is diagnosed in over 300,000 subjects per year in the United States and is a serious condition. Current treatment is mainly supportive to maintain volume homeostasis and correction of biochemical abnormalities

 Why problem exist: There are no Food and Drug Administration (FDA)-approved treatments for AKI, thus it is a serious medical condition for which there are no effective drug therapies.

 New approach to solve the problem: Suramin blocks ischemia reperfusion (I/R) and cisplatin-induced apoptosis in tubular epithelial cells up to 24 hrs after a renal insult, blocks renal inflammation and stimulates proliferation of renal proximal tubular cells.

 Study: This is a prospective, double-blind, randomized, placebo-controlled study to assess the efficacy of suramin in preventing progression to death or dialysis.

 Study duration: The total study duration is expected to be approximately 6 months. This includes a screening period, treatment and observation period of up to 1 week, and a follow-up period of approximately 25 weeks.

 New intervention: Suramin is a multi-functional polysulfonated naphthylurea that has been used for the treatment for trypanosomiasis and other parasitic diseases but has recently shown efficacy in the treatment of furosemide-resistant acute kidney injury (AKI). Rediscovery Life Sciences proposes that suramin’s unique mechanism of action could make it an important new drug candidate for the treatment of AKI in those patients with significant renal tubular injury.

 Study purpose: To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic-unresponsive AKI.

 Sponsor Name: Rediscovery Life Sciences LLC.
PI(s): Dr. Fadda

SaniFit
SNF472

Study Details

12 weeks, with 4-5 weeks for screening and randomization and 4 weeks of follow up.
Patient Information

 Are you a patient on hemodialysis diagnosed with calciphylaxis?

 Calciphylaxis in patients with ESRD is a life-threatening condition with 1-year mortality rates of 45-55%.

There are currently no approved medicinal products or devices for the treatment of Calciphylaxis.

 New intervention: SNF472 is being developed by Sanifit Therapeutics, S.A. (Sanifit) for the treatment of Calciphylaxis in patients with End Stage Renal Disease undergoing hemodialysis.

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

Physician Information

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Standard of Care for the Treatment of Calciphylaxis.

 Target population: Patients with established diagnosis of Calcific Uremic Arteriolopathy – CUA, who are Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening.

 The problem: Calciphylaxis or CUA in patients with ESRD is a life-threatening condition with 1-year mortality rates of 45-55%. In addition, a high rate of mortality was observed within the first few months after diagnosis of CUA.

Why problem exist: This is due to accelerated soft tissue calcification which includes calcification and thrombosis of smaller arteriolar vessels, and eventually leads to progressive and painful necrotic skin ulcerations. There are currently no approved medicinal products or devices for the treatment of CUA, and there is no specific guidelines.

 New approach to solve the problem: SNF472 is a selective calcification inhibitor that works by binding to the growth sites of the hydroxyapatite (HAP) crystals. Chemically, SNF472 is the hexasodium salt of myo-inositol hexaphosphate (IP6, phytate).

 Study: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis.

 Study duration: Duration of treatment will be 12 weeks, with 4-5 weeks for screening and randomization and 4 weeks of follow up.

 New intervention: SNF472 is being developed by Sanifit Therapeutics, S.A. (Sanifit) for the treatment of CUA and cardiovascular calcification (CVC) in patients with ESRD undergoing HD. It is being developed as an orphan drug for the treatment of calciphylaxis (also referred to as Calcific Uremic Arteriolopathy - CUA) and as an orphan drug for treatment of PAD in patients with ESKD on HD. SNF472 is not expected to be metabolized by cytochrome P (CYP) 450 due to its high hydrophilicity.

 Study purpose: To evaluate the efficacy, safety, and tolerability of SNF472 compared with placebo when added to background care for the treatment of CUA.

 Sponsor Name: Sanifit Therapeutics S.A.
PI(s): Dr. Berenji, Dr. Boisken, Dr. Maurice

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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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