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: 16

Brief Summary

The purpose of this 26 week 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 (5)

• Efficacy of Veverimer in improving physical performance as assessed by the the 6-minute walk test (6MWT).

  Visits: Screening to Day 168

• Change in Kidney Disease Quality of Life Physical Function Domain (KDQOL-PFD)

  Visits: Screening to Day 168

• Improvement in Patient Global Impressions Scale - Severity (PGI-S)

  Visits: Screening to Day 168

• Change in peak VO2 (peak volume of oxygen) in participants undergoing CPET (cardiopulmonary exercise testing)

  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:

• Written informed consent.
• ≥ 18 years old (male/female)).
• CKD with eGFR \< 60 mL/min/1.73m²; not expected to need dialysis/ transplant during study.
• 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.

You may not qualify if:

• 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:
• Clinically significant gastroparesis or a history of bariatric surgery.
• Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery, or known active gastric/duodenal ulcers.
• Severe recurrent diarrhea or severe recurrent constipation, in the opinion of the Investigator.
• 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:
• 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.
• Evidence of acute fluid overload or history of recurrent fluid overload, in the opinion of the Investigator.

Sponsors & Collaborators

• Renibus Therapeutics, Inc.: lead

Study Sites (16)

California Institute of Renal Research

Chula Vista, California, 91910, United States

RECRUITING

Academic Medical Research Institute

Los Angeles, California, 90022, United States

RECRUITING

UC Davis Health, Dept of Internal Medicine

Sacramento, California, 95817, United States

RECRUITING

Velocity Clinical Research

Edgewater, Florida, 32132, United States

RECRUITING

Belkis Delgado MD PA

Miami Springs, Florida, 33166, United States

RECRUITING

ClinTrial Research - Oakwater

Orlando, Florida, 32806, United States

RECRUITING

Southeastern Clinical Research Institute

Augusta, Georgia, 30904, United States

RECRUITING

CARE Institute - Boise Kidney

Boise, Idaho, 83706, United States

RECRUITING

Idaho Kidney - CARE Institute

Chubbuck, Idaho, 83201, United States

RECRUITING

CARE Institute - Idaho Falls

Idaho Falls, Idaho, 83401, United States

RECRUITING

Research by Design

Chicago, Illinois, 60643, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Nephrology Associates of Kentuckiana

Louisville, Kentucky, 40205, United States

RECRUITING

New York-Presbyterian Queens

Fresh Meadows, New York, 11365, United States

RECRUITING

Brookview Hills Research Associates

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Clinical Advancement Center

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: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)