Long-term Safety Extension to Study TRCA-301

Tricida, Inc.196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

196

Conditions

Metabolic Acidosis

Interventions

TRC101DRUG

Oral suspension

PlaceboDRUG

Oral suspension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (29)

Investigative Site 55

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.

The incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to withdrawal. For incidence of AEs and SAEs, see Adverse Events Section. For incidence of AEs leading to withdrawal, see endpoint values below.

Time frame: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.

Secondary Outcomes

Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range

Percent of subjects having a change from baseline in serum bicarbonate of at least 4 mEq/L or bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 52).

Time frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.

Change From Baseline in Serum Bicarbonate at the End of Treatment

Change from baseline in serum bicarbonate at the end of treatment (Week 52).

Time frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.

Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment

Change from baseline in the total score of the Kidney Disease Quality of Life Physical Function Domain (KDQOL-PFD) at the end of treatment. The KDQOL is a validated, kidney disease-specific measure of health-related quality of life. For study TRCA-301E, and the parent study TRCA-301, the 10-question Item 3 of the KDQOL, also known as the SF-36 Physical Function subscale, was selected to measure physical functioning and is referenced herein as the KDQOL-PFD. The KDQOL-PFD was chosen as a patient-reported outcome measurement to evaluate the effects of TRC101 on daily activities that may be adversely affected by loss of muscle caused by metabolic acidosis. The minimum score for each of the 10 questions is 0 (physical activity highly limited) and the maximum is 100 (physical activity not limited). The total KDQOL-PFD score is calculated by adding the scores for all 10 questions, for a minimum and maximum possible total KDQOL-PFD score of 0 or 100, respectively.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.