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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: CKD; Metabolic Acidosis
• Intervention / Treatment: Drug: Veverimer; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ayla Rasmussen; Phone Number: 443-569-9228; Email: arasmussen@renibus.com

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91910
      • Recruiting
      • California Institute of Renal Research
    • Los Angeles, California, United States, 90022
      • Recruiting
      • Academic Medical Research Institute
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Health, Dept of Internal Medicine
    • San Diego, California, United States, 92111
      • Recruiting
      • California Institute of Renal Research - San Diego
  • Florida
    • Edgewater, Florida, United States, 32132
      • Recruiting
      • Velocity Clinical Research
    • Miami Springs, Florida, United States, 33166
      • Recruiting
      • Belkis Delgado MD PA
    • Orlando, Florida, United States, 32806
      • Recruiting
      • ClinTrial Research - Oakwater
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Recruiting
      • Southeastern Clinical Research Institute
  • Idaho
    • Boise, Idaho, United States, 83706
      • Recruiting
      • CARE Institute - Boise Kidney
    • Chubbuck, Idaho, United States, 83201
      • Recruiting
      • Idaho Kidney - CARE Institute
    • Idaho Falls, Idaho, United States, 83401
      • Recruiting
      • CARE Institute - Idaho Falls
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Recruiting
      • Research by Design
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Recruiting
      • Nephrology Associates of Kentuckiana
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • JCCT-Clinical Research Consultants
  • New York
    • Fresh Meadows, New York, United States, 11365
      • Recruiting
      • New York-Presbyterian Queens
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Brookview Hills Research Associates
  • Texas
    • Fort Worth, Texas, United States, 76110
      • Recruiting
      • Texas Center for Kidney Disease Research
    • San Antonio, Texas, United States, 78212
      • Recruiting
      • Clinical Advancement Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent.
• ≥ 18 years old (male/female)).
• CKD with eGFR < 60 mL/min/1.73m²; not expected to need dialysis/ transplant during study.
• 2 SBC values 12-21 mmol/L within 6 months pre-screening
• During screening: 2 central SBC values 12-21 mmol/L
• Willing to maintain stable diet .
• Expect to keep oral alkali therapy dose stable.
• Women of childbearing potential: negative pregnancy test and agree to abstinence or contraception.

Exclusion Criteria:

• Any participant deemed by the Investigator to be an inappropriate candidate for physical performance testing (e.g., severe musculoskeletal pain, non-ambulatory status) or with a screening STS5 time < 10 seconds (i.e., very mobile).
• Any participant deemed by the Investigator to be an inappropriate candidate for CPET (e.g., advanced chronic obstructive pulmonary disease [COPD], major cardiovascular [CV] event in last 6 months, systolic blood pressure [SBP] > 200 mmHg or diastolic blood pressure [DBP] > 120 mmHg). Only applicable to sites performing CPET and if the participant will take part in CPET.

• History or current diagnosis of:

  1. Clinically significant gastroparesis or a history of bariatric surgery.
  2. Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery, or known active gastric/duodenal ulcers.
  3. Severe recurrent diarrhea or severe recurrent constipation, in the opinion of the Investigator.
  4. Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria or hypochlorhydria.
• Active Helicobacter pylori infection at screening.
• Active, recurrent, or metastatic malignancy at the start of screening.

• History of malignancy, except under the following conditions:

  1. Carcinoma in situ (e.g., of the cervix, breast, or bladder) that has been completely excised and shows no evidence of residual disease.
  2. Non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been completely excised and show no evidence of recurrence.
  3. Low grade prostate cancer, in the opinion of the Investigator (i.e., no metastasis, Gleason score < 6), with no significant worsening for > 6 months prior to the screening visit.
  4. Any other malignancy that was treated with curative intent and has been in complete remission for ≥ 5 years prior to the screening visit.
• Evidence of acute fluid overload or history of recurrent fluid overload, in the opinion of the Investigator.
• Screening hemoglobin < 10 g/dL.
• Presence of primary respiratory alkalosis, as assessed by venous blood gas (VBG) analysis at time of screening.
• Serum gastrin level > 500 pg/mL.
• Investigational medication administration within 28 days prior to start of screening.
• Use of GI polymer binders or sodium zirconium cyclosilicate within 28 days prior to the start of screening or have an expectation to initiate treatment during the study.
• Use of acid reducing drugs, including potassium competitive acid blockers, H2-blockers or PPIs within 28 days prior to the start of screening or have an expectation to initiate treatment during the study.
• Use of GLP-1 inhibitors within 6 months prior to the start of screening or have an expectation to initiate treatment during the study.
• Participants that are taking any of the following medications and have not been on a stable dose for at least 28 days prior to screening or have an expectation to change dose during the study: diuretics, non-ophthalmic carbonic anhydrase inhibitors, diabetes drugs, RAAS inhibitors, calcium or magnesium supplements, non polymer phosphate binders, and SGLT-2 inhibitors. These medications also should not be started during the study.
• Participants that are taking more than 30 units of insulin daily.
• History of alcoholism or drug/chemical abuse within 1 year prior to the start of screening, in the opinion of the Investigator.
• Current, regular use of inhaled/ingested cannabis/THC products.
• Inability to take the IP or otherwise comply with the protocol.
• Any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results, in the opinion of the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Group 2: 9 g PBO BID
Experimental: Veverimer	Drug: Veverimer; Group 1: 9 g veverimer BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC)	Visits: Screening to Day 168
Efficacy of Veverimer in improving physical performance as assessed by the Sit-to-Stand 5 times test (STS5).	Visits: Screening to Day 168

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Veverimer in improving physical performance as assessed by the the 6-minute walk test (6MWT).		Visits: Screening to Day 168
Change in Kidney Disease Quality of Life Physical Function Domain (KDQOL-PFD)	Patients answer the following 10 questions with: "Yes, limited a lot (0 points)"; "Yes, limited a little (5 points)"; or "No, not limited at all (10 points)"; Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports; Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf; Lifting or carrying groceries; Climbing several flights of stairs; Climbing one flight of stairs; Bending, kneeling, or stooping; Walking more than a mile; Walking several blocks; Walking one block; Bathing or dressing yourself Score can range from 0-100, with a higher score being a better outcome.	Visits: Screening to Day 168
Improvement in Patient Global Impressions Scale - Severity (PGI-S)	Patients answer 1 question throughout the duration of the study: How would you rate your current level of physical functioning (mobility and ability to do every day physical activities)? Poor, Fair, Good, Very good, Excellent. Score can be 1-5, with a higher score being a better outcome.	Visits: Screening to Day 168
Change in peak VO2 (peak volume of oxygen) in participants undergoing CPET (cardiopulmonary exercise testing)		Visits: Screening to Day 168
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]		Visits: Screening to Day 168

Collaborators and Investigators

• Sponsor: Renibus Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CKD; Metabolic Acidosis; Bicarbonate; Veverimer; STS5
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Nutritional and Metabolic Diseases; Acidosis; veverimer
• Other Study ID Numbers: REN-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No