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

NCT07355062 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: REN-012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Metabolic Acidosis; CKD

Keywords

CKD; Metabolic Acidosis; Veverimer; STS5; Bicarbonate

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Efficacy of Veverimer in achieving SBC and responder thresholds.

  Visits: Screening to Day 168

• Performance outcomes (PerfO).

  Visits: Screening to Day 168

• Frailty and muscle mass assessment.

  Visits: Screening to Day 168

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].

  Visits: Screening to Day 168

Study Arms (2)

Veverimer

EXPERIMENTAL

Drug: Veverimer

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Veverimer DRUG

Group 1: 9 g veverimer BID

Veverimer

Placebo DRUG

Group 2: 9 g PBO BID

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Renibus Therapeutics, Inc.: lead

Study Sites (22)

Study Site

Chula Vista, California, 91910, United States

RECRUITING

Study Site

Los Angeles, California, 90022, United States

RECRUITING

Study Site

Sacramento, California, 95817, United States

RECRUITING

Study Site

San Diego, California, 92111, United States

RECRUITING

Study Site

Aurora, Colorado, 80045, United States

RECRUITING

Study Site

Edgewater, Florida, 32132, United States

RECRUITING

Study Site

Miami Springs, Florida, 33166, United States

RECRUITING

Study Site

Orlando, Florida, 32806, United States

RECRUITING

Study Site

Augusta, Georgia, 30904, United States

RECRUITING

Study Site

Boise, Idaho, 83706, United States

RECRUITING

Study Site

Chubbuck, Idaho, 83201, United States

RECRUITING

Study Site

Idaho Falls, Idaho, 83401, United States

RECRUITING

Study Site

Chicago, Illinois, 60643, United States

RECRUITING

Study Site

Indianapolis, Indiana, 46202, United States

RECRUITING

Study Site

Louisville, Kentucky, 40205, United States

RECRUITING

Study Site

Kansas City, Missouri, 64111, United States

RECRUITING

Study Site

Fresh Meadows, New York, 11365, United States

RECRUITING

Study Site

New York, New York, 10016, United States

RECRUITING

Study Site

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Study Site

Fort Worth, Texas, 76110, United States

RECRUITING

Study Site

Houston, Texas, 77054, United States

RECRUITING

Study Site

San Antonio, Texas, 78212, United States

RECRUITING

MeSH Terms

Conditions

Acidosis

Interventions

veverimer

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ayla Rasmussen

CONTACT

443-569-9228; arasmussen@renibus.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 2:1 to veverimer or placebo.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 21, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)