Long-term Safety Extension to Study TRCA-301

• Status: Completed
• Trial end date: 2019-02-22
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• 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.