Long-term Safety Extension to Study TRCA-301

Tricida

Status and phase: Completed; Phase 3

Conditions: Metabolic Acidosis

Treatments: Drug: Placebo; Drug: TRC101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390842

TRCA-301E

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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196 participants in 2 patient groups, including a placebo group

TRC101

Experimental group

Description:

Administered once daily (QD) for 40 weeks

Treatment:

Drug: TRC101

Placebo

Placebo Comparator group

Description:

Administered once daily (QD) for 40 weeks

Treatment:

Drug: Placebo