Phase 3
N=217
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Metabolic Acidosis
Bottom Line
View on ClinicalTrials.gov: NCT03317444 ↗Enrolled (actual)
217
Serious AEs
2.3%
Results posted
Apr 2021
Primary outcome: Primary: Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range — 59.2; 22.5; 55.8; 21.3 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TRC101 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tricida, Inc.
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range |
59.2; 22.5; 55.8; 21.3; 50.0; 16.9 | < 0.0001 sig |
| SECONDARY Change From Baseline to End of Treatment in Serum Bicarbonate |
4.42; 1.78 | < 0.0001 sig |
Summary
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily.
The maximum study duration is anticipated to be up to 16 weeks.
Eligibility Criteria
Key Inclusion Criteria
- Blood bicarbonate level of 12 to 20 mEq/L.
- Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
- Stable kidney function defined as <=20% variability in eGFR during screening period.
Key Exclusion Criteria
- Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
- Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
- Heart or kidney transplant.
- Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
- Change in doses to alkali therapy in the 4 weeks prior to screening.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
- Serum calcium <= 8.0 mg/dL at screening.
- Planned initiation of renal replacement therapy within 12 weeks following randomization.
- Use of polymeric binder drugs within 14 days prior to screening.
Data sourced from ClinicalTrials.gov (NCT03317444). 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.