Phase 3
Completed N=196
Long-term Safety Extension to Study TRCA-301
Metabolic Acidosis
Source: ClinicalTrials.gov NCT03390842 ↗
Enrolled (actual)
196
Serious AEs
3.1%
Results posted
Oct 2021
Primary outcomePrimary: Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. — 0; 1.2 percentage of participants
◆ Published Evidence
Established
88citations · ~13 / year
Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension.
Summary
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.
Linked Publications (2)
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Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension.
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Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. |
0; 1.2 | — |
| SECONDARY Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range |
62.7; 37.8 | = 0.0015 sig |
| SECONDARY Change From Baseline in Serum Bicarbonate at the End of Treatment |
4.70; 2.71 | = 0.0002 sig |
| SECONDARY Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment |
11.42; -0.71 | < 0.0001 sig |
| SECONDARY Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment |
-4.28; -1.42 | < 0.0001 sig |
Eligibility Criteria
Key Inclusion Criteria
- Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.
- Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.
Key Exclusion Criteria
- Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.
- Planned initiation of renal replacement therapy within 6 months following study entry.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
- Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
Data sourced from ClinicalTrials.gov (NCT03390842) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.