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

ConditionsCKDMetabolic Acidosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenibus Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Veverimer

    Drug

    Group 1: 9 g veverimer BID

  • Placebo

    Drug

    Group 2: 9 g PBO BID

Treatment groups

150 Participants
are divided into 2 treatment groups
Group 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 168
2

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

Secondary outcomes

1

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).

Time frame
Visits: Screening to Day 168
2

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.

Time frame
Visits: Screening to Day 168
3

Frailty and muscle mass assessment.

Change in performance on 6-minute walk test 6MWT.

Time frame
Visits: Screening to Day 168
4

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

Time frame
Visits: Screening to Day 168

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Renibus Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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