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Clinical Trial Details

Trial ID: L1546
Source ID: NCT03087058
Associated Drug: Patiromer
Title: Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
Acronym: EMERALD
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03087058/results
Conditions: Hyperkalemia
Interventions: DRUG: Patiromer|DRUG: Patiromer|DRUG: Patiromer
Outcome Measures: Primary: Change in Serum Potassium Levels, from Baseline to Day 14 | Secondary: Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L, Day 14: Initial PD / Dose Finding Phase. Week 26: Long-Term Treatment Phase., Day 14 and Week 26
Sponsor/Collaborators: Sponsor: Vifor Pharma, Inc.
Gender: ALL
Age: CHILD
Phases: PHASE2
Enrollment: 23
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-07-07
Completion Date: 2021-04-30
Results First Posted: 2022-09-26
Last Update Posted: 2022-10-19
Locations: Investigator Site 1107, Palo Alto, California, 94394, United States|Investigator Site 1101, Kansas City, Kansas, 64108, United States|Investigator Site 1103, Baltimore, Maryland, 21287, United States|Investigator Site 1102, Bronx, New York, 10467, United States|Investigator Site 1105, Cincinnati, Ohio, 45229, United States|Investigator Site 1108, Pittsburgh, Pennsylvania, 15224, United States|Investigator Site 1104, Amarillo, Texas, 79106, United States|Investigator Site 1109, Dallas, Texas, 75235, United States|Investigator Site 1113, Houston, Texas, 77030, United States|Investigator Site 1106, Madison, Wisconsin, 53792, United States|Investigator Site 1401, Sofia, 1606, Bulgaria|Investigator Site 1902, Vancouver, British Columbia, V5Z 4H4, Canada|Investigator Site 3915, Tbilisi, 0121, Georgia|Investigator Site 3913, Tbilisi, 0144, Georgia|Investigator Site 3911, Tbilisi, 0159, Georgia|Investigator Site 3912, Tbilisi, 0159, Georgia|Investigator Site 3914, Tbilisi, 0159, Georgia|Investigator Site 4312, Essen, 45147, Germany|Investigator Site 4313, Hannover, 30625, Germany|Investigator Site 4311, Heidelberg, 69120, Germany|Investiagor Site 4314, Köln, 50937, Germany|Investigator Site 5401, Bialystok, 15-274, Poland|Investigator Site 5404, Gdansk, 80-952, Poland|Investigator Site 5406, Krakow, 30-663, Poland|Investigator Site 5402, Lodz, 93-338, Poland|Investigator Site 5403, Lublin, 20-093, Poland|Investigator Site 5405, Warsaw, 02-091, Poland|Investigator Site 7906, Dnipropetrovs'k, 49000, Ukraine|Investigator Site 7903, Kharkiv, 61075, Ukraine|Investigator Site 7904, Kyiv, 04050, Ukraine
URL: https://clinicaltrials.gov/show/NCT03087058

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress