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

September 1, 2026 updated by: Renibus Therapeutics, Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Veverimer in Adults With CKD and Metabolic Acidosis

The purpose of this 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Study Site
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Study Site
      • Sacramento, California, United States, 95817
        • Recruiting
        • Study Site
      • San Diego, California, United States, 92111
        • Recruiting
        • Study Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Study Site
    • Florida
      • Edgewater, Florida, United States, 32132
        • Recruiting
        • Study Site
      • Margate, Florida, United States, 33063
        • Recruiting
        • Study Site
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • Study Site
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Study Site
    • Georgia
      • Augusta, Georgia, United States, 30904
        • Recruiting
        • Study Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Study Site
      • Chubbuck, Idaho, United States, 83201
        • Recruiting
        • Study Site
      • Idaho Falls, Idaho, United States, 83401
        • Recruiting
        • Study Site
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Recruiting
        • Study Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Study Site
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Study Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Study Site
    • New York
      • Fresh Meadows, New York, United States, 11365
        • Recruiting
        • Study Site
      • New York, New York, United States, 10016
        • Recruiting
        • Study Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Study Site
    • Texas
      • Fort Worth, Texas, United States, 76110
        • Recruiting
        • Study Site
      • Houston, Texas, United States, 77054
        • Recruiting
        • Study Site
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have provided written informed consent prior to participation in the study.
  • Male or female participants 18 years of age or older.
  • Diagnosed with CKD (eGFR < 60 mL/min/1.73m2) and not expected to require renal replacement therapy (dialysis or kidney transplant) throughout the duration of the study.
  • Within 6 months prior to screening have at least two SBC between 12 and 20 mmol/L, inclusive. If only one historical SBC is available, a second SBC may be drawn on screening visit S1 and analyzed by the local laboratory.
  • Within screening period have two central laboratory SBC (at least 24 hours apart and more than 4 hours after food) between 12 and 21 mmol/L, inclusive.
  • Willing to keep food consumption similar to baseline throughout the entire study.
  • If taking oral alkali therapy, dose has been stable for at least 28 days prior to the start of screening and is expected to remain stable throughout the study.
  • Women who are of childbearing potential must have a negative pregnancy test and agree to abstinence or to use contraception.

Exclusion Criteria:

  • Any participant deemed by the Investigator to be an inappropriate candidate for PerfO testing (e.g., severe musculoskeletal pain, non-ambulatory status), inability to complete STS5 without support or with a screening STS5 time < 10 seconds.

  • 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 including gastrectomy, or known active gastric/duodenal ulcers.
    3. Severe recurrent diarrhea or constipation, as assessed by the Investigator.
    4. Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria or hypochlorhydria.
  • Ineligible per REVIVE GastroScreen test.
  • Use of GI polymer binders or sodium zirconium cyclosilicate within 14 days prior to the start of screening or have an expectation to initiate treatment during the study.
  • Use of acid reducing drugs, including PPIs, H2RAs or P-CABs within 14 days prior to the start of screening or have an expectation to initiate treatment during the study. Very sporadic use (one time per week or less) may be acceptable, as assessed by the Investigator.
  • Initiation of GLP-1 receptor agonists within 6 months prior to the start of screening, or expectation to initiate use during the study. Participants that have been on a GLP-1 receptor agonist for more than 6 months and have maintained a stable dose and steady body weight for at least one month prior to the start of screening may be considered for enrollment, upon Medical Monitor review. GLP-1 receptor agonists also should not be started during the study.
  • Participants that are taking any of the following medications and have not been on a stable dose for at least 14 days prior to the start of 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.
  • 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.
  • Two or more hospitalizations within 12 months prior to the start of screening or a hospitalization within the last 3 months prior to the start of screening due to fluid overload, heart failure, acute kidney injury (AKI) or electrolyte disorders, including hyperkalemia. Participants that have not been hospitalized within the past 3 months and whose condition is stable may be considered for enrollment.
  • Screening hemoglobin < 9 g/dL.
  • Low bicarbonate value(s) at time of screening that are due to underlying primary respiratory alkalosis.
  • Investigational medication administration within 28 days prior to start of screening.
  • Participants that are taking an average of > 30 units of insulin daily, unless recent (within last 6 months) hemoglobin A1C is < 6.5%.
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Visits: Screening to Day 168
Visits: Screening to Day 168
Efficacy of Veverimer in improving physical performance as assessed by the Sit-to-Stand 5 times test (STS5).
Time Frame: Visits: Screening to Day 168
Visits: Screening to Day 168

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Veverimer in achieving SBC and responder thresholds.
Time Frame: Visits: Screening to Day 168
Change from baseline in SBC. Achievement of SBC thresholds (> 4 mmol/L increase from baseline and/or > 23 mmol/L).
Visits: Screening to Day 168
Performance outcomes (PerfO).
Time Frame: Visits: Screening to Day 168

Change in Patient Global Impression of Change of Physical Functioning (PGI-C) Patients answer 1 question: How would you rate your current level of physical functioning (mobility and ability to do everyday physical activities) compared to the beginning of the study? Much better, Moderately better, A little better, No change, A little worse, Moderately worse, Much worse. Lower score is a better outcome.

Change in Patient Global Impressions Scale - Severity (PGI-S) Patients answer 1 question: How would you rate your current level of physical functioning (mobility and ability to do everyday physical activities)? Poor, Fair, Good, Very good, Excellent. Higher score is a better outcome.
Visits: Screening to Day 168
Frailty and muscle mass assessment.
Time Frame: Visits: Screening to Day 168
Change in performance on 6-minute walk test 6MWT.
Visits: Screening to Day 168
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Time Frame: Visits: Screening to Day 168
Visits: Screening to Day 168

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renibus Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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