Clinical trial NCT03390842: Long-term Safety Extension to Study TRCA-301
Official title: A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Acidosis
Keywords: blood bicarbonate, kidney disease
Lead sponsor: Tricida, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.
timeFrame: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.
Secondary outcomes:
measure: Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
timeFrame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
measure: Change From Baseline in Serum Bicarbonate at the End of Treatment
timeFrame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
measure: Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment
timeFrame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
measure: Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment
timeFrame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site 55
state: Arizona
city: Los Angeles
country: United States
facility: Investigative Site 91
state: California
city: Hialeah
country: United States
facility: Investigative Site 59
state: Florida
city: Hollywood
country: United States
facility: Investigative Site 93
state: Florida
city: Lauderdale Lakes
country: United States
facility: Investigative Site 92
state: Florida
city: Atlanta
country: United States
facility: Investigative Site 95
state: Georgia
city: San Antonio
country: United States
facility: Investigative Site 52
state: Texas
city: Sofia
country: Bulgaria
facility: Investigative Site 11
city: Tbilisi
country: Georgia
facility: Investigative Site 31
city: Tbilisi
country: Georgia
facility: Investigative Site 32
city: Tbilisi
country: Georgia
facility: Investigative Site 33
city: Tbilisi
country: Georgia
facility: Investigative Site 34
city: Tbilisi
country: Georgia
facility: Investigative Site 35
city: Tbilisi
country: Georgia
facility: Investigative Site 36
city: Tbilisi
country: Georgia
facility: Investigative Site 37
city: Budapest
country: Hungary
facility: Investigative Site 41
city: Budapest
country: Hungary
facility: Investigative Site 46
city: Hódmezővásárhely
country: Hungary
facility: Investigative Site 49
city: Kistarcsa
country: Hungary
facility: Investigative Site 44
city: Vršac
country: Serbia
facility: Investigative Site 61
city: Jesenice
country: Slovenia
facility: Investigative Site 72
city: Maribor
country: Slovenia
facility: Investigative Site 71
city: Kharkiv
country: Ukraine
facility: Investigative Site 81
city: Kharkiv
country: Ukraine
facility: Investigative Site 83
city: Kharkiv
country: Ukraine
facility: Investigative Site 87
city: Kharkiv
country: Ukraine
facility: Investigative Site 88
city: Kyiv
country: Ukraine
facility: Investigative Site 84
city: Kyiv
country: Ukraine
facility: Investigative Site 85
city: Kyiv
country: Ukraine
facility: Investigative Site 86
Study officials:
affiliation: Tricida, Inc.
name: Clinical Operations
role: STUDY_DIRECTOR
References:
citation: Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension. Lancet. 2019 Aug 3;394(10196):396-406. doi: 10.1016/S0140-6736(19)31388-1. Epub 2019 Jun 24.
citation: Mathur VS, Wesson DE, Tangri N, Li E, Bushinsky DA. Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial. BMC Nephrol. 2022 Feb 25;23(1):82. doi: 10.1186/s12882-022-02690-1.