A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenibus Therapeutics, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Veverimer
DrugGroup 1: 9 g veverimer BID
Placebo
DrugGroup 2: 9 g PBO BID
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: VeverimerExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC)
Time frame
Visits: Screening to Day 1682
Efficacy of Veverimer in improving physical performance as assessed by the Sit-to-Stand 5 times test (STS5).
Time frame
Visits: Screening to Day 168Secondary outcomes
1
Efficacy of Veverimer in improving physical performance as assessed by the the 6-minute walk test (6MWT).
Time frame
Visits: Screening to Day 1682
Change in Kidney Disease Quality of Life Physical Function Domain (KDQOL-PFD)
Patients answer the following 10 questions with: "Yes, limited a lot (0 points)"; "Yes, limited a little (5 points)"; or "No, not limited at all (10 points)" * Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports * Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf * Lifting or carrying groceries * Climbing several flights of stairs * Climbing one flight of stairs * Bending, kneeling, or stooping * Walking more than a mile * Walking several blocks * Walking one block * Bathing or dressing yourself Score can range from 0-100, with a higher score being a better outcome.
Time frame
Visits: Screening to Day 1683
Improvement in Patient Global Impressions Scale - Severity (PGI-S)
Patients answer 1 question throughout the duration of the study: How would you rate your current level of physical functioning (mobility and ability to do every day physical activities)? Poor, Fair, Good, Very good, Excellent. Score can be 1-5, with a higher score being a better outcome.
Time frame
Visits: Screening to Day 1684
Change in peak VO2 (peak volume of oxygen) in participants undergoing CPET (cardiopulmonary exercise testing)
Time frame
Visits: Screening to Day 168Sponsors and contacts
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Source ClinicalTrials.gov