Veverimer for Metabolic Acidosis in CKD
This study is testing a drug called veverimer to see if it can safely and effectively treat metabolic acidosis in adults with moderate-to-severe chronic kidney disease (CKD). Metabolic acidosis is a condition where your body has too much acid. You might be eligible if you are 18 or older, have CKD (with an eGFR less than 60 mL/min/1.73m2), and are not expected to need dialysis or a kidney transplant during the study. We will measure changes in your blood bicarbonate levels and your physical performance (using a sit-to-stand test) to see if veverimer is working. This study plans to enroll 150 participants, but its current status is unclear.
- Study design
- This study is testing veverimer against a placebo (an inactive substance) in 150 participants. Participants will receive either 9g of veverimer twice a day or 9g of placebo twice a day.
- What's involved
- Participants will have visits from screening up to Day 168, where blood bicarbonate levels and physical performance will be measured.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for efficacy and safety measurements up to Day 168.
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NCT07355062
A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis
Recruiting
PHASE3Ages 18+InterventionalTreatmentRenibus Therapeutics, Inc.
~150 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:VeverimerPlacebo
At a glance
Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC)
Measured over Visits: Screening to Day 168
+1 more outcome measured
Conditions
Where it's being run
22 sites across 12 statesCalifornia4
Florida3
Idaho3
Texas3
New York2
Colorado1
Georgia1
Illinois1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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:
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:
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.
What this trial measures
- 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