Long-term Safety Extension to Study TRCA-301

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2019-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Acidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TRC101

Administered once daily (QD) for 40 weeks

Group Type EXPERIMENTAL

TRC101

Intervention Type DRUG

Oral suspension

Placebo

Administered once daily (QD) for 40 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral suspension

Interventions

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TRC101

Oral suspension

Intervention Type DRUG

Placebo

Oral suspension

Intervention Type DRUG

Other Intervention Names

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Veverimer

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Operations

Role: STUDY_DIRECTOR

Tricida, Inc.

Kyiv, , Ukraine

Site Status

Investigative Site 86

Kyiv, , Ukraine

Site Status

Countries

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United States Bulgaria Georgia Hungary Serbia Slovenia Ukraine

References

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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.

Reference Type RESULT

PMID: 31248662 (View on PubMed)

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.

Reference Type DERIVED

PMID: 35216581 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TRCA-301E

Identifier Type: -

Identifier Source: org_study_id

Long-term Safety Extension to Study TRCA-301

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

TRC101

TRC101

Placebo

Placebo

Interventions

TRC101

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Tricida, Inc.

Responsible Party

Principal Investigators

Clinical Operations

Locations

Investigative Site 55

Investigative Site 91

Investigative Site 59

Investigative Site 93

Investigative Site 92

Investigative Site 95

Investigative Site 52

Investigative Site 11

Investigative Site 31

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Investigative Site 33

Investigative Site 34

Investigative Site 35

Investigative Site 36

Investigative Site 37

Investigative Site 41

Investigative Site 46

Investigative Site 49

Investigative Site 44

Investigative Site 61

Investigative Site 72

Investigative Site 71

Investigative Site 81

Investigative Site 83

Investigative Site 87

Investigative Site 88

Investigative Site 84

Investigative Site 85

Investigative Site 86

Countries

References

Provided Documents

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

TRCA-301E