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Veverimer for metabolic acidosis in adults with chronic kidney disease.

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)

PHASE3 · Renibus Therapeutics, Inc. · NCT07355062

This 26-week trial will test whether veverimer can raise bicarbonate levels and improve outcomes in adults with moderate-to-severe CKD and metabolic acidosis.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorRenibus Therapeutics, Inc. (industry)
Locations16 sites (Chula Vista, California and 15 other locations)
Trial IDNCT07355062 on ClinicalTrials.gov

What this trial studies

This 26-week, phase 3, randomized placebo-controlled study compares oral veverimer to placebo in adults with CKD (eGFR <60 mL/min/1.73 m²) and confirmed metabolic acidosis (serum bicarbonate 12–21 mmol/L). Participants will maintain stable diet and background oral alkali therapy while central lab bicarbonate measurements and physical performance tests (including STS5 and CPET) are used to measure efficacy and safety. The trial's primary focus is correction of metabolic acidosis and safety over 26 weeks, with secondary outcomes including physical function. The study is sponsored by Renibus Therapeutics and conducted at multiple clinical sites in California.

Who should consider this trial

Good fit: Adults 18 years or older with chronic kidney disease (eGFR <60 mL/min/1.73 m²), two confirmed serum bicarbonate values of 12–21 mmol/L, not on dialysis and able to complete physical performance testing are appropriate candidates.

Not a fit: People already on or expected to start dialysis/transplant during the study, those without metabolic acidosis, or those unable to perform physical testing or with recent major cardiovascular events are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, veverimer could reduce metabolic acidosis without additional oral alkali and improve physical function for people with CKD.

How similar studies have performed: Earlier phase 2 and phase 3 studies of veverimer have shown increases in serum bicarbonate and some improvements in physical function, but longer-term outcome data are still limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Chula Vista, California and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: CKD, Metabolic Acidosis, Veverimer, STS5, Bicarbonate

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.