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Recruiting Phase 3 NCT07355062

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

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Trial Parameters

Condition CKD
Sponsor Renibus Therapeutics, Inc.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-13
Completion 2027-06
Interventions
VeverimerPlacebo

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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.

Eligibility Criteria

Inclusion Criteria: * Written informed consent. * ≥ 18 years old (male/female)). * CKD with eGFR \< 60 mL/min/1.73m²; not expected to need dialysis/ transplant during study. * 2 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. Exclusion Criteria: * 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 pressu

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