Overview
Long-term Safety Extension to Study TRCA-301
Status:
Completed
Completed
Trial end date:
2019-02-22
2019-02-22
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Tricida, Inc.
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.