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

Last updated: March 20, 2026
Sponsor: Renibus Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Distal Renal Tubular Acidosis

Arginase Deficiency

Metabolic Disorders

Treatment

Veverimer

Placebo

Clinical Study ID

NCT07355062
REN-012
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent.

  • ≥ 18 years old (male/female)).

  • CKD with eGFR < 60 mL/min/1.73m²; not expected to need dialysis/ transplant duringstudy.

  • 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 orcontraception.

Exclusion

Exclusion Criteria:

  • Any participant deemed by the Investigator to be an inappropriate candidate forphysical performance testing (e.g., severe musculoskeletal pain, non-ambulatorystatus) 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 diastolicblood pressure [DBP] > 120 mmHg). Only applicable to sites performing CPET and ifthe 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 knownactive gastric/duodenal ulcers.

  3. Severe recurrent diarrhea or severe recurrent constipation, in the opinion ofthe Investigator.

  4. Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria orhypochlorhydria.

  • 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 beencompletely 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., nometastasis, Gleason score < 6), with no significant worsening for > 6 monthsprior to the screening visit.

  4. Any other malignancy that was treated with curative intent and has been incomplete remission for ≥ 5 years prior to the screening visit.

  • Evidence of acute fluid overload or history of recurrent fluid overload, in theopinion 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 ofscreening.

  • Use of GI polymer binders or sodium zirconium cyclosilicate within 28 days prior tothe start of screening or have an expectation to initiate treatment during thestudy.

  • 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 anexpectation to initiate treatment during the study.

  • Use of GLP-1 inhibitors within 6 months prior to the start of screening or have anexpectation to initiate treatment during the study.

  • Participants that are taking any of the following medications and have not been on astable dose for at least 28 days prior to screening or have an expectation to changedose during the study: diuretics, non-ophthalmic carbonic anhydrase inhibitors,diabetes drugs, RAAS inhibitors, calcium or magnesium supplements, non polymerphosphate binders, and SGLT-2 inhibitors. These medications also should not bestarted 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 ofscreening, 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 illnessthat would significantly decrease study compliance or jeopardize the safety of theparticipant or affect the validity of the trial results, in the opinion of theInvestigator.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Veverimer
Phase: 3
Study Start date:
January 13, 2026
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Academic Medical Research Institute

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • Research Site

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Belkis Delgado MD PA

    Miami Springs, Florida 33166
    United States

    Active - Recruiting

  • Research Site

    Miami Springs, Florida 33166
    United States

    Active - Recruiting

  • Research Site

    Miami Springs 4164223, Florida 4155751 33166
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60643
    United States

    Active - Recruiting

  • Research by Design

    Chicago, Illinois 60643
    United States

    Active - Recruiting

  • Research Site

    Chicago 4887398, Illinois 4896861 60643
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Nephrology Associates of Kentuckiana

    Louisville, Kentucky 40205
    United States

    Active - Recruiting

  • Research Site

    Louisville, Kentucky 40205
    United States

    Active - Recruiting

  • Research Site

    Louisville 4299276, Kentucky 6254925 40205
    United States

    Site Not Available

  • New York-Presbyterian Queens

    Fresh Meadows, New York 11365
    United States

    Active - Recruiting

  • Brookview Hills Research Associates

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Clinical Advancement Center

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • Research Site

    San Antonio 4726206, Texas 4736286 78212
    United States

    Site Not Available

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