Veverimer for metabolic acidosis in adults with chronic kidney disease.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Veverimer in Adults With CKD and Metabolic Acidosis
Run by Renibus Therapeutics, Inc. · NCT07355062 · Data updated 2026-11-12
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Renibus Therapeutics, Inc. Industry-sponsored |
| Locations | 28 sites (Chula Vista, California and 27 other locations) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07355062 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Study Site
Chula Vista, California, United States Recruiting -
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Los Angeles, California, United States Recruiting -
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Sacramento, California, United States Recruiting -
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San Diego, California, United States Recruiting -
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Aurora, Colorado, United States Recruiting -
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Newark, Delaware, United States Recruiting
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Edgewater, Florida, United States Recruiting -
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Margate, Florida, United States Recruiting -
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Miami Springs, Florida, United States Recruiting -
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Orlando, Florida, United States Recruiting -
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Boise, Idaho, United States Recruiting -
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Chubbuck, Idaho, United States Recruiting -
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Idaho Falls, Idaho, United States Recruiting -
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Chicago, Illinois, United States Recruiting -
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Indianapolis, Indiana, United States Recruiting -
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Louisville, Kentucky, United States Recruiting -
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New Orleans, Louisiana, United States Recruiting -
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Detroit, Michigan, United States Recruiting -
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Pontiac, Michigan, United States Recruiting -
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Kansas City, Missouri, United States Recruiting -
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Fresh Meadows, New York, United States Recruiting -
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New York, New York, United States Recruiting -
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Winston-Salem, North Carolina, United States Recruiting -
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Fort Worth, Texas, United States Recruiting -
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Houston, Texas, United States Recruiting -
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San Antonio, Texas, United States Recruiting -
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Van Vleck, Texas, United States Recruiting -
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Augusta, Georgia, United States Terminated
Study contacts
- Study coordinator: Ayla Rasmussen
- Email: arasmussen@renibus.com
- Phone: 443-569-9228
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.