CKDPhase 3NCT07355062
A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis
A Phase 3 study testing Veverimer in people with CKD and Metabolic Acidosis, run by Renibus Therapeutics, Inc. at 28 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD, Metabolic Acidosis
- What is being tested?
- Veverimer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 28 sitesUnited States
- Study dates
- 13 Jan 2026to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Clinically significant gastroparesis or a history of bariatric surgery.
- Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery including gastrectomy, or known active gastric/duodenal ulcers.
- Severe recurrent diarrhea or constipation, as assessed by the Investigator.
- Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria or hypochlorhydria.
Show all 26Show fewer
- 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:
- Carcinoma in situ (e.g., of the cervix, breast, or bladder) that has been completely excised and shows no evidence of residual disease.
- Non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been completely excised and show no evidence of recurrence.
- 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.
- 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.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
United States28 sites, 27 recruiting
- Terminated
Study Site
Augusta, Georgia, 30904
- Recruiting
Study Site
Aurora, Colorado, 80045
- Recruiting
Study Site
Boise, Idaho, 83706
- Recruiting
Study Site
Chicago, Illinois, 60643
- Recruiting
Study Site
Chubbuck, Idaho, 83201
- Recruiting
Study Site
Chula Vista, California, 91910
- Recruiting
Study Site
Detroit, Michigan, 48202
- Recruiting
Study Site
Edgewater, Florida, 32132
- Recruiting
Study Site
Fort Worth, Texas, 76110
- Recruiting
Study Site
Fresh Meadows, New York, 11365
- Recruiting
Study Site
Houston, Texas, 77054
- Recruiting
Study Site
Idaho Falls, Idaho, 83401
- Recruiting
Study Site
Indianapolis, Indiana, 46202
- Recruiting
Study Site
Kansas City, Missouri, 64111
- Recruiting
Study Site
Los Angeles, California, 90022
- Recruiting
Study Site
Louisville, Kentucky, 40205
- Recruiting
Study Site
Margate, Florida, 33063
- Recruiting
Study Site
Miami Springs, Florida, 33166
- Recruiting
Study Site
New Orleans, Louisiana, 70112
- Recruiting
Study Site
New York, New York, 10016
- Recruiting
Study Site
Newark, Delaware, 19713
- Recruiting
Study Site
Orlando, Florida, 32806
- Recruiting
Study Site
Pontiac, Michigan, 48341
- Recruiting
Study Site
Sacramento, California, 95817
- Recruiting
Study Site
San Antonio, Texas, 78212
- Recruiting
Study Site
San Diego, California, 92111
- Recruiting
Study Site
Van Vleck, Texas, 77482
- Recruiting
Study Site
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- CKD, Metabolic Acidosis
- Being tested
- Veverimer, Placebo
- Keywords
- CKD, Metabolic Acidosis, Veverimer, STS5, Bicarbonate
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeverimerDrug
Group 1: 9 g veverimer BID
PlaceboDrug
Group 2: 9 g PBO BID
| Study group | Role | What they receive |
|---|---|---|
| Veverimer | Experimental | Not described Receives: Drug: Veverimer |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC)
Measured: Visits: Screening to Day 168
Efficacy of Veverimer in improving physical performance as assessed by the Sit-to-Stand 5 times test (STS5).
Measured: Visits: Screening to Day 168
Secondary outcomes (4)
Efficacy of Veverimer in achieving SBC and responder thresholds.
Change from baseline in SBC. Achievement of SBC thresholds (> 4 mmol/L increase from baseline and/or > 23 mmol/L).
Measured: Visits: Screening to Day 168
Performance outcomes (PerfO).
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.
Measured: Visits: Screening to Day 168
Frailty and muscle mass assessment.
Change in performance on 6-minute walk test 6MWT.
Measured: Visits: Screening to Day 168
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Measured: Visits: Screening to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start13 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized 2:1 to veverimer or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renibus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355062
- Sponsor's protocol ID
- REN-012
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07355062
- Acronym / sponsor ID
- REN-012
- Conditions
- CKD, Metabolic Acidosis
- Keywords
- CKD, Metabolic Acidosis, Veverimer, STS5, Bicarbonate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Renibus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 2:1 to veverimer or placebo.
| Arm | Type | Receives |
|---|---|---|
| Veverimer | Experimental | Drug: Veverimer |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeverimerGroup 1: 9 g veverimer BID | Drug | Veverimer |
| PlaceboGroup 2: 9 g PBO BID | Drug | Placebo |
Primary outcome
Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC)
Time frame: 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
4 secondary outcomes
Efficacy of Veverimer in achieving SBC and responder thresholds.
Time frame: Visits: Screening to Day 168
Performance outcomes (PerfO).
Time frame: Visits: Screening to Day 168
Frailty and muscle mass assessment.
Time frame: Visits: Screening to Day 168
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Time frame: Visits: Screening to Day 168
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for CKD
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Veverimer in people with CKD and Metabolic Acidosis, run by Renibus Therapeutics, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayla Rasmussen (443-569-9228, arasmussen@renibus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC) (time frame: Visits: Screening to Day 168). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.