Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07355062

A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis

Led by Renibus Therapeutics, Inc. · Updated on 2026-04-22

150

Participants Needed

16

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this 26 week study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.

CONDITIONS

Official Title

A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent is provided.
  • Adults 18 years old or older, male or female.
  • Diagnosed with chronic kidney disease with eGFR less than 60 mL/min/1.73m² and 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.
  • During screening, two central serum bicarbonate values between 12 and 21 mmol/L.
  • Willingness to maintain a stable diet.
  • Expectation to keep oral alkali therapy dose stable.
  • Women of childbearing potential must have a negative pregnancy test and agree to abstinence or use contraception.
Not Eligible

You will not qualify if you...

  • Considered inappropriate for physical performance testing (e.g., severe musculoskeletal pain, non-ambulatory) or have a screening Sit-to-Stand 5 times test time less than 10 seconds.
  • Considered inappropriate for cardiopulmonary exercise testing (CPET) due to conditions like advanced COPD, recent major cardiovascular event, or very high blood pressure.
  • History or current diagnosis of significant gastrointestinal disorders such as gastroparesis, bariatric surgery, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
  • Severe recurrent diarrhea or constipation.
  • Diagnosed with pernicious anemia, atrophic or autoimmune gastritis, achlorhydria, or hypochlorhydria.
  • Active Helicobacter pylori infection at screening.
  • Active, recurrent, or metastatic cancer at screening.
  • History of certain malignancies not meeting specific remission or treatment criteria.
  • Evidence or history of acute or recurrent fluid overload.
  • Screening hemoglobin less than 10 g/dL.
  • Presence of primary respiratory alkalosis.
  • Serum gastrin level greater than 500 pg/mL.
  • Use of investigational medication within 28 days before screening.
  • Use or planned use of certain gastrointestinal binders or acid-reducing drugs within 28 days before screening.
  • Use or planned use of GLP-1 inhibitors within 6 months before screening.
  • Unstable use or planned changes of specific medications including diuretics, carbonic anhydrase inhibitors, diabetes drugs, RAAS inhibitors, supplements, phosphate binders, and SGLT-2 inhibitors.
  • Taking more than 30 units of insulin daily.
  • History of alcoholism or drug abuse within 1 year before screening.
  • Current regular use of cannabis/THC products.
  • Inability to take study medication or comply with protocol.
  • Any medical condition or uncontrolled disease that could reduce study compliance or participant safety as judged by the Investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 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

Velocity Clinical Research

Edgewater, Florida, United States, 32132

Actively Recruiting

5

Belkis Delgado MD PA

Miami Springs, Florida, United States, 33166

Actively Recruiting

6

ClinTrial Research - Oakwater

Orlando, Florida, United States, 32806

Actively Recruiting

7

Southeastern Clinical Research Institute

Augusta, Georgia, United States, 30904

Actively Recruiting

8

CARE Institute - Boise Kidney

Boise, Idaho, United States, 83706

Actively Recruiting

9

Idaho Kidney - CARE Institute

Chubbuck, Idaho, United States, 83201

Actively Recruiting

10

CARE Institute - Idaho Falls

Idaho Falls, Idaho, United States, 83401

Actively Recruiting

11

Research by Design

Chicago, Illinois, United States, 60643

Actively Recruiting

12

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

13

Nephrology Associates of Kentuckiana

Louisville, Kentucky, United States, 40205

Actively Recruiting

14

New York-Presbyterian Queens

Fresh Meadows, New York, United States, 11365

Actively Recruiting

15

Brookview Hills Research Associates

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

16

Clinical Advancement Center

San Antonio, Texas, United States, 78212

Actively Recruiting

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Research Team

A

Ayla Rasmussen

CONTACT

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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