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Chronic Kidney Disease
Current Studies
RENIBUS
(Metabolic Acidocis)
Study Details
30 weeks
Patient Information
Do you have Chronic Kidney Disease (CKD) and low bicarbonate levels (metabolic acidosis)?
You may qualify for the REVIVE Study evaluating Veverimer, a potential new treatment designed to safely correct metabolic acidosis and improve physical function in people with CKD. Participants will receive study-related evaluations, laboratory testing, and close medical monitoring throughout the study.
Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.
Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.
Physician Information
Target population: Adults 18 years of age or older with moderate-to-severe Chronic Kidney Disease (CKD) (eGFR < 60 mL/min/1.73m²) and metabolic acidosis, with serum bicarbonate concentrations between 12 and 21 mmol/L.
The problem: Patients with CKD often develop metabolic acidosis, a condition in which the kidneys cannot adequately maintain the body's acid-base balance, resulting in low serum bicarbonate levels. This condition contributes to worsening kidney disease and reduced physical function.
Why the problem exists: As kidney function declines, the kidneys lose their ability to excrete acid and generate bicarbonate, leading to chronic metabolic acidosis. This can accelerate CKD progression, increase mortality risk, cause muscle wasting, inflammation, bone disease, and impair physical performance. Current treatments such as sodium bicarbonate are often limited by tolerability and safety concerns.
New approach to solve the problem: Veverimer is a novel, non-absorbed oral polymer that binds hydrochloric acid (HCl) in the gastrointestinal tract and removes it through the stool. This mechanism increases serum bicarbonate levels without adding sodium or potassium, potentially providing a safer treatment option for CKD patients with metabolic acidosis.
Study: Researchers are studying an investigational medication called Veverimer to determine whether it can safely correct metabolic acidosis, improve physical function, and help adults with chronic kidney disease feel and function better.
Study duration: Up to 30 weeks per participant:
- Screening: up to 4 weeks
- Treatment: 24 weeks
- Follow-up/End of Study: 2 weeks
New intervention: Veverimer, an investigational oral proton and chloride binder administered as a powder mixed with water, compared with placebo. Participants are randomized 2:1 to veverimer or placebo.
Study purpose: To evaluate whether veverimer can:
- Increase serum bicarbonate levels
- Improve physical function
- Improve quality of life
- Improve symptoms related to metabolic acidosis
- Demonstrate safety and tolerability in adults with CKD and metabolic acidosis.
Sponsor Name: Renibus Therapeutics, Inc.
PI(s): Dr. Adam Horeish & Dr. Dylan Steer
JADE
(IgA Nephropathy)
Study Details
118–122 weeks total (about 2.3 years)
Patient Information
Do You Have IgA Nephropathy (IgAN)?
Researchers are studying JADE101, an investigational treatment designed to target the underlying cause of IgA Nephropathy. JADE101 may help reduce protein leaking into the urine, protect kidney function, and slow disease progression by blocking APRIL, a protein involved in producing the abnormal antibodies that damage the kidneys. Participants will receive study medication, regular health monitoring, and study-related care throughout the trial.
Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.
Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.
Physician Information
Target population: Adults 18 to 60 years old with biopsy-confirmed IgA Nephropathy (IgAN) who:
- Continue to have significant protein in their urine despite standard treatment
- Have kidney function (eGFR) of at least 30 mL/min/1.73m²
- Are already taking stable doses of ACE inhibitors or ARBs (standard kidney-protective medications)
The problem: IgA Nephropathy (IgAN) is a chronic autoimmune kidney disease in which abnormal immune proteins build up in the kidneys, causing inflammation and damage. Over time, kidney function can decline, and many patients eventually develop kidney failure.
Why the problem exists: In IgAN, the immune system produces abnormal forms of IgA antibodies. These abnormal antibodies form immune complexes that become trapped in the kidneys, leading to:
- Ongoing inflammation
- Protein leaking into the urine (proteinuria)
- Progressive kidney damage
- Eventual loss of kidney function
Even with currently available treatments, many patients continue to have persistent proteinuria and remain at risk for chronic kidney disease and kidney failure. Approximately 30–45% of patients may progress to end-stage kidney disease within 20–25 years.
New approach to solve the problem: Researchers are targeting a protein called APRIL, which plays a key role in producing the abnormal IgA antibodies that drive IgAN.
By blocking APRIL, JADE101 may:
- Reduce production of harmful IgA antibodies
- Lower proteinuria
- Slow or prevent kidney damage
- Preserve kidney function over time
This approach aims to treat the underlying cause of the disease rather than simply managing symptoms.
Study: Approximately 30 participants will be enrolled. All participants will receive JADE101 and will be assigned to one of two dosing schedules:
- Every 8 weeks (Q8W)
- Every 12 weeks (Q12W)
Study duration: Each participant will be in the study for approximately:
- 118–122 weeks total (about 2.3 years)
New intervention: JADE101 is an investigational monoclonal antibody designed to block APRIL, a key driver of IgA Nephropathy.
Study purpose:
The study is designed to evaluate:
- Safety and tolerability of JADE101
- Whether JADE101 can reduce protein in the urine (proteinuria)
- Whether JADE101 can help preserve kidney function
- Effects on disease-related biomarkers such as APRIL, IgA, and Gd-IgA1
- The optimal dosing schedule for future studies
Sponsor Name: Jade Biosciences, Inc.
PI(s): Dr. Adam Horeish
AstraZeneca PEAK
(Venous Catheter)
Study Details
Approximately 15 months
Patient Information
Are you 18 years of age or older with kidney failure and receiving hemodialysis through a central venous catheter?
The PEAK Study is evaluating AZD7760, a potential new treatment that may help prevent serious bloodstream infections caused by Staphylococcus aureus in people receiving dialysis through a catheter.
Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.
Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.
Physician Information
Target population: Adults (18 years and older) with End-Stage Kidney Disease (ESKD) who receive hemodialysis through a central venous catheter (CVC).
The problem: Patients on hemodialysis who use a central venous catheter have a high risk of developing serious bloodstream infections, especially infections caused by Staphylococcus aureus (S. aureus).
Why problem exists: Central venous catheters provide a pathway for bacteria to enter the bloodstream. Patients with kidney failure receiving regular dialysis are particularly vulnerable to these infections, which can lead to hospitalization, serious illness, and even death.
New approach to solve the problem: Researchers are studying a new antibody-based treatment designed to help the immune system prevent S. aureus bloodstream infections before they occur.
Study: The PEAK Study is testing a new investigational medication called AZD7760 that may help prevent serious bloodstream infections in people with kidney failure who receive dialysis through a catheter. Researchers want to learn whether this treatment is safe and how it works in the body.
Study duration: Approximately 15 months for dialysis patients:
- Up to 28 days of screening
- Two infusions given 3 months apart
- 12 months of follow-up after the last infusion
New intervention: AZD7760, an investigational monoclonal antibody combination consisting of suvratoxumab and AZD7745, given by intravenous (IV) infusion.
Study purpose: To evaluate the safety, pharmacokinetics (how the drug moves through the body), and immune response to AZD7760, while supporting its development as a treatment to help prevent Staphylococcus aureus bloodstream infections in dialysis patients with central venous catheters.
Sponsor Name: AstraZeneca
PI(s): Dr. Adam Horeish
Akebia
(FSGS)
Study Details
Up to 60 weeks
Patient Information
Do you have Focal Segmental Glomerulosclerosis (FSGS)?
Researchers are evaluating Praliciguat, a potential new treatment that may help reduce proteinuria and slow kidney damage in adults with biopsy-confirmed FSGS. Eligible participants may receive study-related care and monitoring throughout this clinical trial.
Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.
Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.
Physician Information
Target population: Adults 18 years of age or older with biopsy-confirmed Focal Segmental Glomerulosclerosis (FSGS) diagnosed within 3 years of screening and receiving maximally tolerated ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB) therapy.
The problem: FSGS is a serious kidney disease that causes protein leakage into the urine (proteinuria), progressive kidney damage, and can ultimately lead to kidney failure (ESKD).
Why problem exists: FSGS damages specialized kidney cells called podocytes, which are responsible for maintaining the kidney's filtration barrier. Current therapies mainly reduce proteinuria but do not directly address the underlying disease process. Many patients fail to achieve remission and remain at high risk for kidney function decline and kidney failure.
New approach to solve the problem: Praliciguat is designed to stimulate the nitric oxide–soluble guanylate cyclase–cGMP pathway (NO-sGC-cGMP), which may help restore podocyte function, improve kidney blood flow, reduce inflammation and fibrosis, decrease proteinuria, and slow progression of FSGS.
Study: Researchers are studying an investigational oral medication called Praliciguat to determine whether it can reduce protein leaking into the urine and help protect kidney function in adults with FSGS, a rare kidney disease that can lead to kidney failure.
Study duration: Up to 60 weeks, consisting of:
- Screening period: up to 8 weeks
- Treatment period: 48 weeks
- Safety follow-up: 4 weeks
New intervention: Praliciguat, an oral soluble guanylate cyclase (sGC) stimulator, compared with placebo. Participants receive daily oral dosing with titration up to 40 mg as tolerated.
Study purpose: To evaluate the efficacy and safety of praliciguat in reducing proteinuria in adults with FSGS who are receiving standard background therapy with ACE inhibitors or ARBs. The primary endpoint is change in urine protein-to-creatinine ratio (UPCR) at Week 24.
Sponsor Name: Akebia Therapeutics, Inc.
PI(s): Dr. Jill Meyer
AztraZeneca Elevate
(GLP-1)
Study Details
Approximately 2.5 to 4.5 years
Patient Information
Do you have Chronic Kidney Disease (CKD)?
Researchers are studying an investigational medication called Elecoglipron to see if it can help slow kidney disease progression and reduce the risk of serious kidney complications and death in people living with CKD.
Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.
Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.
Physician Information
Target population: Adults 18 years or older with Chronic Kidney Disease (CKD), with or without Type 2 Diabetes, who are receiving standard kidney-protective treatments.
The problem: CKD is a progressive disease that causes the kidneys to gradually lose their ability to filter waste and excess fluid from the blood. Over time, this can lead to kidney failure, dialysis, kidney transplant, hospitalization, and death.
Why the problem exists: Many people with CKD continue to lose kidney function despite currently available treatments, putting them at risk for serious kidney and cardiovascular complications.
New approach to solve the problem: Researchers are studying Elecoglipron, an investigational medication that may help protect kidney function and reduce the risk of serious kidney and heart-related complications when added to standard CKD treatment.
Study: Researchers are studying an investigational medication called Elecoglipron to see if it can help slow kidney disease, reduce the risk of dialysis or kidney transplant, and help people with Chronic Kidney Disease live longer and healthier lives.
Study duration: Approximately 2.5 to 4.5 years per participant.
New intervention: Elecoglipron (AZD5004)
Participants will receive either:
- Elecoglipron 65 mg once daily, or
- Placebo once daily
All participants will also receive standard kidney care, including dapagliflozin (Farxiga) if tolerated.
Study purpose: To determine whether elecoglipron can help:
- Slow the progression of kidney disease
- Reduce kidney-related complications
- Reduce the risk of death in people with CKD
Sponsor Name: AstraZeneca
PI(s): Dr. Adam Horeish, Dr. Fharak Maa Chip & Dr. Dylan Steer
ARGENX
(IgAN Nephropathy)
Study Details
72 weeks
Patient Information
Do you have IgA Nephropathy (IgAN)?
The VERDANT Study is evaluating ARGX-121, a potential new treatment designed to target the underlying cause of IgAN by reducing harmful IgA antibodies that damage the kidneys.
Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.
Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.
Physician Information
Target population: Adults 18 years and older with biopsy-confirmed Primary IgA Nephropathy (IgAN) who remain on stable, maximally tolerated background therapy and continue to have persistent proteinuria despite treatment.
The problem: IgA Nephropathy (IgAN) is the most common form of primary glomerulonephritis worldwide and can progressively damage the kidneys, eventually leading to kidney failure, dialysis, or kidney transplantation.
Why the problem exists: In IgAN, abnormal IgA antibodies form immune complexes that become deposited in the kidneys. These deposits trigger inflammation and scarring, causing ongoing kidney damage. Even with current therapies, many patients continue to experience declining kidney function over time.
New approach to solve the problem: Researchers are studying ARGX-121, a first-in-class monoclonal antibody that directly targets IgA through a dual mechanism:
- Blocks IgA from binding to its receptor (FcαRI)
- Removes harmful IgA from circulation ("sweeping")
This may reduce formation of pathogenic immune complexes and help prevent kidney injury.
Study: Researchers are studying ARGX-121, an investigational medication designed to target the abnormal IgA proteins that cause IgA Nephropathy. The goal is to see whether ARGX-121 can reduce kidney damage, lower protein in the urine, and help preserve kidney function.
Study duration: Approximately 72 weeks (about 17 months) per participant
New intervention: ARGX-121 (Subcutaneous Injection)
Study purpose: To determine whether ARGX-121 can:
- Reduce proteinuria (protein in the urine)
- Slow kidney disease progression
- Improve kidney function (eGFR)
- Reduce harmful IgA levels and immune complexes
- Improve quality of life
- Demonstrate safety and tolerability in patients with IgAN.
Sponsor Name: Argenx
PI(s): Dr. Adam Horeish, Dr. Fharak Maa Chip & Dr. Dylan Steer
FINALITY Moonraker
(Heart Failure)
Study Details
Approximately 30 months
Patient Information
Do you have Heart Failure with Reduced Ejection Fraction (HFrEF) and cannot take medications like spironolactone or eplerenone?
You may qualify for the FINALITY-HF Study evaluating finerenone, a potential new treatment designed to reduce heart failure events and improve outcomes. Participants will receive study-related care, laboratory monitoring, and close medical follow-up throughout the study.
Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.
Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.
Physician Information
Target population: Adults 18 years of age or older with Heart Failure with Reduced Ejection Fraction (HFrEF) who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists (sMRAs) such as spironolactone or eplerenone.
The problem: Many patients with HFrEF remain at high risk for heart failure hospitalizations, urgent heart failure visits, and cardiovascular death despite available treatments. Although sMRAs are guideline-recommended therapies, many patients cannot take them due to safety or tolerability concerns.
Why the problem exists: Steroidal MRAs are underutilized because of concerns about:
- Hyperkalemia (high potassium)
- Worsening kidney function
- Hypotension
- Sexual side effects (gynecomastia, menstrual irregularities, erectile dysfunction)
As a result, many eligible HFrEF patients are left without a proven therapy that could improve outcomes.
New approach to solve the problem: Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that may provide the benefits of MRA therapy with improved tolerability and fewer hormonal side effects compared with traditional steroidal MRAs
Study: Researchers are studying whether finerenone, a non-steroidal mineralocorticoid receptor antagonist, can safely reduce heart failure hospitalizations and cardiovascular death in people with heart failure who cannot tolerate or are not eligible for traditional MRA medications such as spironolactone or eplerenone.
Study duration: Average participant duration: approximately 30 months.
New intervention: Finerenone (BAY 94-8862) administered orally at doses of 10 mg, 20 mg, or 40 mg once daily, compared with matching placebo.
Study purpose: To determine whether finerenone can:
- Reduce cardiovascular death
- Reduce heart failure events (hospitalizations and urgent HF visits)
- Improve heart failure outcomes
- Demonstrate safety and tolerability in HFrEF patients who cannot take steroidal MRAs.
Sponsor Name: CPC Clinical Research
PI(s): Dr. Adam Horeish & Dr. Dylan Steer
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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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