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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

196

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Dec 2017

Shorter than P25 for phase_3

Geographic Reach

7 countries

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

December 20, 2017

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

October 22, 2021

Completed

Last Updated

October 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

December 28, 2017

Results QC Date

September 24, 2021

Last Update Submit

September 24, 2021

Conditions

Metabolic Acidosis

Keywords

blood bicarbonate, kidney disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
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
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
Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment
Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.

Study Arms (2)

TRC101

EXPERIMENTAL

Administered once daily (QD) for 40 weeks

Drug: TRC101

Placebo

PLACEBO COMPARATOR

Administered once daily (QD) for 40 weeks

Drug: Placebo

Interventions

TRC101DRUG

Oral suspension

Also known as: Veverimer

TRC101

PlaceboDRUG

Oral suspension

Placebo

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Tricida, Inc.lead

Study Sites (29)

Investigative Site 55

Phoenix, Arizona, 85032, United States

Location

Investigative Site 91

Los Angeles, California, 90022, United States

Location

Investigative Site 59

Hialeah, Florida, 33015, United States

Location

Investigative Site 93

Hollywood, Florida, 33024, United States

Location

Investigative Site 92

Lauderdale Lakes, Florida, 33313, United States

Location

Investigative Site 95

Atlanta, Georgia, 30342, United States

Location

Investigative Site 52

San Antonio, Texas, 78215, United States

Location

Investigative Site 11

Sofia, Bulgaria

Location

Investigative Site 31

Tbilisi, Georgia

Location

Investigative Site 32

Tbilisi, Georgia

Location

Investigative Site 33

Tbilisi, Georgia

Location

Investigative Site 34

Tbilisi, Georgia

Location

Investigative Site 35

Tbilisi, Georgia

Location

Investigative Site 36

Tbilisi, Georgia

Location

Investigative Site 37

Tbilisi, Georgia

Location

Investigative Site 41

Budapest, Hungary

Location

Investigative Site 46

Budapest, Hungary

Location

Investigative Site 49

Hódmezővásárhely, Hungary

Location

Investigative Site 44

Kistarcsa, Hungary

Location

Investigative Site 61

Vršac, Serbia

Location

Investigative Site 72

Jesenice, Slovenia

Location

Investigative Site 71

Maribor, Slovenia

Location

Investigative Site 81

Kharkiv, Ukraine

Location

Investigative Site 83

Kharkiv, Ukraine

Location

Investigative Site 87

Kharkiv, Ukraine

Location

Investigative Site 88

Kharkiv, Ukraine

Location

Investigative Site 84

Kyiv, Ukraine

Location

Investigative Site 85

Kyiv, Ukraine

Location

Investigative Site 86

Kyiv, Ukraine

Location

Related Publications (2)

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.
PMID: 31248662RESULT
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.
PMID: 35216581DERIVED

MeSH Terms

Conditions

AcidosisKidney Diseases

Interventions

veverimer

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title: Medical Information
Organization: Tricida, Inc.

Study Officials

Clinical Operations
Tricida, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

December 20, 2017

Primary Completion

February 22, 2019

Study Completion

February 22, 2019

Last Updated

October 22, 2021

Results First Posted

October 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing: Will not share

Locations

UA(7)BU(1)HU(4)SL(2)US(7)GE(7)SE(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

TRC101

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations