Phase 2
N=135
Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
Acidosis
Bottom Line
View on ClinicalTrials.gov: NCT02809183 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE — 14; 13; 9; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); TRC101 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tricida, Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE |
14; 13; 9; 17; 17; 11 | — |
| PRIMARY Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group |
-0.2; 3.2; 3.0; 3.7 | 0.5547 |
| SECONDARY Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo |
-0.2; 3.2; 3.0; 3.7 | < 0.0001 sig |
| SECONDARY Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group |
3.3 | < 0.0001 sig |
| SECONDARY Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo |
-0.2; 3.3 | < 0.0001 sig |
| SECONDARY Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo |
4; 18; 14; 19; 2; 14 | < 0.0001 sig |
| SECONDARY Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group |
3.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo |
-0.2; 3.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group |
3.0; 3.5 | 0.4214 |
| SECONDARY Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo |
4; 23; 2; 14; 1; 12 | < 0.0001 sig |
Summary
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD).
The maximum study duration per subject was anticipated to be up to 42 days.
Eligibility Criteria
Inclusion Criteria
- Estimated glomerular filtration rate (eGFR) of 20 to <60 mL/min/1.73m2
- Serum bicarbonate level of 12 to 20 mEq/L
Exclusion Criteria
- Any level of low serum bicarbonate that, in the opinion of the Investigator, requires emergency intervention.
- Severe comorbid conditions other than chronic kidney disease.
- Chronic obstructive pulmonary disease.
- Anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, H2-blockers, or proton pump inhibitors.
- Excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (NSAIDs), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.
Data sourced from ClinicalTrials.gov (NCT02809183). 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.