Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

• ClinicalTrials.gov Identifier: NCT03317444
• Recruitment Status: Completed
• First Posted: October 23, 2017
• Last Update Posted: March 26, 2019
• Sponsor: Tricida, Inc.
• Information provided by (Responsible Party): Tricida, Inc.

Tracking Information

• First Submitted Date: October 11, 2017
• First Posted Date: October 23, 2017
• Last Update Posted Date: March 26, 2019
• Actual Study Start Date: September 26, 2017
• Actual Primary Completion Date: May 4, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2017)

Change from baseline in blood bicarbonate. [ Time Frame: Week 12 ]

Comparison of TRC101 and placebo with regard to the proportions of subjects with change from baseline in blood bicarbonate ≥ 4 mEq/L or with blood bicarbonate in the normal range (22 to 29 mEq/L).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: October 19, 2017)

Adverse events, serious adverse events, withdrawal of treatment due to an adverse event. [ Time Frame: Up to Week 14 ]

Number and percentage of subjects with treatment-emergent adverse events (TEAEs), number and percentage of subjects experiencing TEAEs by severity, causality, seriousness, and action taken with regard to study drug by treatment group. TEAEs leading to discontinuation of study treatment will be summarized by treatment group.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
• Official Title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Metabolic Acidosis

Intervention

• Drug: TRC101
  Oral suspension
  Other Name: Veverimer
• Drug: Placebo
  Oral suspension

Study Arms

• Experimental: TRC101
  Administered once daily (QD) for 12 weeks
  Intervention: Drug: TRC101
• Placebo Comparator: Placebo
  Administered once daily (QD) for 12 weeks
  Intervention: Drug: Placebo

• Publications *: Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Veverimer versus placebo in patients with metabolic acidosis associated with chronic kidney disease: a multicentre, randomised, double-blind, controlled, phase 3 trial. Lancet. 2019 Apr 6;393(10179):1417-1427. doi: 10.1016/S0140-6736(18)32562-5. Epub 2019 Mar 8.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2018): 217
• Original Estimated Enrollment (submitted: October 19, 2017): 210
• Actual Study Completion Date: May 15, 2018
• Actual Primary Completion Date: May 4, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Croatia, Georgia, Hungary, Serbia, Slovenia, Ukraine, United States

Administrative Information

• NCT Number: NCT03317444
• Other Study ID Numbers: TRCA-301; 2016-003825-41 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Tricida, Inc.
• Study Sponsor: Tricida, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Yuri Stasiv, PhD; Tricida, Inc.

• PRS Account: Tricida, Inc.
• Verification Date: March 2019