Actively Recruiting
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Veverimer in Adults With CKD and Metabolic Acidosis (The REVIVE Study)
Led by Renibus Therapeutics, Inc. · Updated on 2026-06-02
150
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating veverimer for adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis in this 26-week study. The main goal is to assess whether veverimer can safely improve serum bicarbonate levels and physical performance in this population. This Phase 3 trial is led by Renibus Therapeutics, Inc. and uses a randomized, double-blind design to compare veverimer with placebo. Participants are randomly assigned to receive either 9 grams of veverimer twice daily or a matching placebo for 26 weeks. The study includes detailed monitoring of physical function using tests like the Sit-to-Stand 5 times test and the 6-minute walk test. Additional assessments include quality of life surveys, patient global impressions, and cardiopulmonary exercise testing. Safety is closely monitored through recording adverse events during the study period. During the trial, participants will have regular visits from screening through Day 168 to measure changes in serum bicarbonate and physical performance. They will undergo various tests including blood tests, exercise tests, and questionnaires to evaluate kidney function and quality of life. Researchers will also track safety by noting any side effects or health changes. The total participation time is 26 weeks, with assessments scheduled throughout to capture treatment effects and tolerability.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- 18 years old or older (male or female)
- Chronic kidney disease with eGFR less than 60 mL/min/1.73m², not expected to need dialysis or transplant during the study
- Two serum bicarbonate values between 12 and 21 mmol/L within 6 months before screening
- Two serum bicarbonate values between 12 and 21 mmol/L at screening
- Willingness to maintain a stable diet
- Expect to keep oral alkali therapy dose stable
- Women of childbearing potential must have a negative pregnancy test and agree to abstinence or contraception
You will not qualify if you...
- Unsuitable for physical performance testing or Sit-to-Stand 5 times test time less than 10 seconds
- Unsuitable for cardiopulmonary exercise testing due to severe lung or heart conditions or high blood pressure
- History or current diagnosis of severe gastrointestinal disorders, gastroparesis, or bariatric surgery
- Active Helicobacter pylori infection
- Active, recurrent, or metastatic cancer at screening
- History of certain cancers unless in remission or fully treated for at least 5 years
- Evidence or history of acute or recurrent fluid overload
- Hemoglobin less than 10 g/dL at screening
- Presence of primary respiratory alkalosis
- Serum gastrin level above 500 pg/mL
- Use of investigational drugs within 28 days before screening
- Use or expected use of certain gastrointestinal binders or acid-reducing drugs within 28 days before screening
- Use of GLP-1 inhibitors within 6 months before screening
- Unstable doses or expected dose changes of specific medications including diuretics, diabetes drugs, and others
- Use of more than 30 units of insulin daily
- History of alcoholism or drug abuse within 1 year
- Regular use of cannabis or THC products
- Inability to take study medication or comply with the protocol
- Any medical condition or serious illness that could affect safety or study results as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks (168 days)
Participants receive either Veverimer or placebo as part of the study treatment.
Visits from Day 1 to Day 168
Trial Site Locations
Total: 19 locations
1
California Institute of Renal Research
Chula Vista, California, United States, 91910
Actively Recruiting
2
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Actively Recruiting
3
UC Davis Health, Dept of Internal Medicine
Sacramento, California, United States, 95817
Actively Recruiting
4
California Institute of Renal Research - San Diego
San Diego, California, United States, 92111
Actively Recruiting
5
Velocity Clinical Research
Edgewater, Florida, United States, 32132
Actively Recruiting
6
Belkis Delgado MD PA
Miami Springs, Florida, United States, 33166
Actively Recruiting
7
ClinTrial Research - Oakwater
Orlando, Florida, United States, 32806
Actively Recruiting
8
Southeastern Clinical Research Institute
Augusta, Georgia, United States, 30904
Actively Recruiting
9
CARE Institute - Boise Kidney
Boise, Idaho, United States, 83706
Actively Recruiting
10
Idaho Kidney - CARE Institute
Chubbuck, Idaho, United States, 83201
Actively Recruiting
11
CARE Institute - Idaho Falls
Idaho Falls, Idaho, United States, 83401
Actively Recruiting
12
Research by Design
Chicago, Illinois, United States, 60643
Actively Recruiting
13
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
14
Nephrology Associates of Kentuckiana
Louisville, Kentucky, United States, 40205
Actively Recruiting
15
JCCT-Clinical Research Consultants
Kansas City, Missouri, United States, 64111
Actively Recruiting
16
New York-Presbyterian Queens
Fresh Meadows, New York, United States, 11365
Actively Recruiting
17
Brookview Hills Research Associates
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
18
Texas Center for Kidney Disease Research
Fort Worth, Texas, United States, 76110
Actively Recruiting
19
Clinical Advancement Center
San Antonio, Texas, United States, 78212
Actively Recruiting
Research Team
A
Ayla Rasmussen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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