Long-term Safety Extension to Study TRCA-301
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|ClinicalTrials.gov Identifier: NCT03390842|
Recruitment Status : Completed
First Posted : January 4, 2018
Results First Posted : October 22, 2021
Last Update Posted : October 22, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Metabolic Acidosis||Drug: TRC101 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||December 20, 2017|
|Actual Primary Completion Date :||February 22, 2019|
|Actual Study Completion Date :||February 22, 2019|
Administered once daily (QD) for 40 weeks
Other Name: Veverimer
Placebo Comparator: Placebo
Administered once daily (QD) for 40 weeks
- Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. [ Time Frame: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E. ]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.
- Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range [ Time Frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. ]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).
- Change From Baseline in Serum Bicarbonate at the End of Treatment [ 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 (Week 52).
- Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment [ 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 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.
- Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment [ 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 duration of repeated chair stand test at the end of treatment (Week 52). The five-times repeated chair stand test was used as a measure of lower extremity muscle strength. In this test, the time it took for a subject to repeatedly stand from a chair five times was recorded. This test is among the group of measures (gait speed, chair stand, and balance tests) comprising the Short Physical Performance Battery (SPPB), which has been used as a predictive tool for possible disability and for monitoring physical functioning in older people.
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390842
|Study Director:||Clinical Operations||Tricida, Inc.|
Documents provided by Tricida, Inc.:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Tricida, Inc.|
|Other Study ID Numbers:||
|First Posted:||January 4, 2018 Key Record Dates|
|Results First Posted:||October 22, 2021|
|Last Update Posted:||October 22, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
blood bicarbonate, kidney disease