Long-term Safety Extension to Study TRCA-301
Completed · Phase 3 · Has a placebo group
Conditions studied: Metabolic Acidosis
In brief
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.
Key facts
- Study ID
- NCT03390842
- Run by
- Tricida, Inc.
- People needed
- 196
- Starts
- 2017-12-20
- Expected to finish
- 2019-02-22
- Last updated by the study team
- 2021-10-22
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Investigative Site 55 — Phoenix, Arizona, United States
- Investigative Site 91 — Los Angeles, California, United States
- Investigative Site 59 — Hialeah, Florida, United States
- Investigative Site 93 — Hollywood, Florida, United States
- Investigative Site 92 — Lauderdale Lakes, Florida, United States
- Investigative Site 95 — Atlanta, Georgia, United States
- Investigative Site 52 — San Antonio, Texas, 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
Full record on ClinicalTrials.gov
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