Long-term Safety Extension to Study TRCA-301
- Registration Number
- NCT03390842
- Lead Sponsor
- Tricida, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRC101 TRC101 Administered once daily (QD) for 40 weeks Placebo Placebo Administered once daily (QD) for 40 weeks
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. 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.
- Secondary Outcome Measures
Name Time Method 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. 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 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 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 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.
Trial Locations
- Locations (29)
Investigative Site 35
🇬🇪Tbilisi, Georgia
Investigative Site 36
🇬🇪Tbilisi, Georgia
Investigative Site 37
🇬🇪Tbilisi, Georgia
Investigative Site 86
🇺🇦Kyiv, Ukraine
Investigative Site 85
🇺🇦Kyiv, Ukraine
Investigative Site 31
🇬🇪Tbilisi, Georgia
Investigative Site 61
🇷🇸Vršac, Serbia
Investigative Site 81
🇺🇦Kharkiv, Ukraine
Investigative Site 87
🇺🇦Kharkiv, Ukraine
Investigative Site 88
🇺🇦Kharkiv, Ukraine
Investigative Site 32
🇬🇪Tbilisi, Georgia
Investigative Site 33
🇬🇪Tbilisi, Georgia
Investigative Site 34
🇬🇪Tbilisi, Georgia
Investigative Site 46
🇭🇺Budapest, Hungary
Investigative Site 49
🇭🇺Hódmezővásárhely, Hungary
Investigative Site 44
🇭🇺Kistarcsa, Hungary
Investigative Site 83
🇺🇦Kharkiv, Ukraine
Investigative Site 41
🇭🇺Budapest, Hungary
Investigative Site 84
🇺🇦Kyiv, Ukraine
Investigative Site 11
🇧🇬Sofia, Bulgaria
Investigative Site 71
🇸🇮Maribor, Slovenia
Investigative Site 92
🇺🇸Lauderdale Lakes, Florida, United States
Investigative Site 59
🇺🇸Hialeah, Florida, United States
Investigative Site 72
🇸🇮Jesenice, Slovenia
Investigative Site 55
🇺🇸Phoenix, Arizona, United States
Investigative Site 91
🇺🇸Los Angeles, California, United States
Investigative Site 93
🇺🇸Hollywood, Florida, United States
Investigative Site 95
🇺🇸Atlanta, Georgia, United States
Investigative Site 52
🇺🇸San Antonio, Texas, United States