| Outcome Measures: |
Primary: 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: Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range, 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)., 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, Change from baseline in serum bicarbonate at the end of treatment (Week 52)., 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, 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., 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, 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., Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
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| Locations: |
Investigative Site 55, Phoenix, Arizona, 85032, United States|Investigative Site 91, Los Angeles, California, 90022, United States|Investigative Site 59, Hialeah, Florida, 33015, United States|Investigative Site 93, Hollywood, Florida, 33024, United States|Investigative Site 92, Lauderdale Lakes, Florida, 33313, United States|Investigative Site 95, Atlanta, Georgia, 30342, United States|Investigative Site 52, San Antonio, Texas, 78215, United States|Investigative Site 11, Sofia, Bulgaria|Investigative Site 31, Tbilisi, Georgia|Investigative Site 32, Tbilisi, Georgia|Investigative Site 33, Tbilisi, Georgia|Investigative Site 34, Tbilisi, Georgia|Investigative Site 35, Tbilisi, Georgia|Investigative Site 36, Tbilisi, Georgia|Investigative Site 37, Tbilisi, Georgia|Investigative Site 41, Budapest, Hungary|Investigative Site 46, Budapest, Hungary|Investigative Site 49, Hódmezővásárhely, Hungary|Investigative Site 44, Kistarcsa, Hungary|Investigative Site 61, Vršac, Serbia|Investigative Site 72, Jesenice, Slovenia|Investigative Site 71, Maribor, Slovenia|Investigative Site 81, Kharkiv, Ukraine|Investigative Site 83, Kharkiv, Ukraine|Investigative Site 87, Kharkiv, Ukraine|Investigative Site 88, Kharkiv, Ukraine|Investigative Site 84, Kyiv, Ukraine|Investigative Site 85, Kyiv, Ukraine|Investigative Site 86, Kyiv, Ukraine
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