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Clinical Trial Details

Trial ID: L1465
Source ID: NCT03317444
Associated Drug: Trc101
Title: Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03317444/results
Conditions: Metabolic Acidosis
Interventions: DRUG: TRC101|DRUG: Placebo
Outcome Measures: Primary: Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range, Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit)., Baseline to Week 12 | Secondary: Change From Baseline to End of Treatment in Serum Bicarbonate, Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate, Baseline to Week 12
Sponsor/Collaborators: Sponsor: Tricida, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 217
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-09-26
Completion Date: 2018-05-15
Results First Posted: 2021-04-26
Last Update Posted: 2021-04-26
Locations: Investigative Site 55, Phoenix, Arizona, 85032, United States|Investigative Site 56, Chula Vista, California, 91910, United States|Investigative Site 91, Los Angeles, California, 90022, United States|Investigative Site 59, Hialeah, Florida, 33015, United States|Investigative Site 54, Hollywood, Florida, 33021, United States|Investigative Site 93, Hollywood, Florida, 33024, United States|Investigative Site 92, Lauderdale Lakes, Florida, 33313, United States|Investigative Site 51, Tampa, Florida, 33614, United States|Investigative Site 57, Winter Park, Florida, 32789, United States|Investigative Site 95, Atlanta, Georgia, 30342, United States|Investigative Site 53, Shreveport, Louisiana, 71101, United States|Investigative Site 58, Flushing, New York, 11355, United States|Investigative Site 52, San Antonio, Texas, 78215, United States|Investigative Site 11, Sofia, Bulgaria|Investigative Site 21, Zagreb, Croatia|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 43, Baja, Hungary|Investigative Site 48, Balatonfüred, Hungary|Investigative Site 41, Budapest, Hungary|Investigative Site 46, Budapest, Hungary|Investigative Site 45, Hatvan, Hungary|Investigative Site 49, Hódmezővásárhely, Hungary|Investigative Site 44, Kistarcsa, Hungary|Investigative Site 42, Miskolc, Hungary|Investigative Site 47, Mosonmagyaróvár, Hungary|Investigative Site 64, Belgrade, Serbia|Investigative Site 65, Belgrade, Serbia|Investigative Site 61, Vršac, Serbia|Investigative Site 62, Zrenjanin, 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
URL: https://clinicaltrials.gov/show/NCT03317444

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress