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Clinical Trial Details

Trial ID: L1101
Source ID: NCT01810939
Associated Drug: Patiromer
Title: A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
Acronym: OPAL
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01810939/results
Conditions: Chronic Kidney Disease (CKD)|Hyperkalemia (HK)
Interventions: DRUG: Patiromer|DRUG: Placebo
Outcome Measures: Primary: Change in Serum Potassium From Part A Baseline to Part A Week 4, The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3)., Part A Baseline to Part A Week 4|Change in Serum Potassium From Part B Baseline, Change in Serum Potassium from Part B Baseline to either: Part B Week 4 visit, if the participant's serum potassium remained ≥ 3.8 mEq/L and \< 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant's serum potassium was \< 3.8 mEq/L or ≥ 5.5 mEq/L., Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L | Secondary: Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4, Week 4|Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B, Part B Baseline to Part B Week 8|Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B, Part B Baseline to Part B Week 8
Sponsor/Collaborators: Sponsor: Relypsa, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 243
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2013-02
Completion Date: 2013-08
Results First Posted: 2015-12-15
Last Update Posted: 2021-06-03
Locations: Investigator Site 3121, Azusa, California, 91702, United States|Investigator Site 3133, Los Angeles, California, 90025, United States|Investigator Site 3103, Sacramento, California, 95825, United States|Investigator Site 3129, Santa Barbara, California, 93110, United States|Investigator Site 3130, Ventura, California, 93003, United States|Investigator Site 3105, Edgewater, Florida, 32132, United States|Investigator Site 3113, Hollywood, Florida, 33021, United States|Investigator Site 3106, Port Charlotte, Florida, 33952, United States|Investigator Site 3120, Augusta, Georgia, 30909, United States|Investigator Site 3102, Farmington, Missouri, 63640, United States|Investigator Site 3104, Kansas City, Missouri, 64111, United States|Investigator Site 3134, Flushing, New York, 11355, United States|Investigator Site 3107, Bethlehem, Pennsylvania, 18017, United States|Investigator Site 3110, San Antonio, Texas, 78229, United States|Investigator Site 1103, Karlovac, 47000, Croatia|Investigator Site 1102, Osijek, 31000, Croatia|Investigator Site 1104, Zagreb, 10000, Croatia|Investigator Site 1105, Zagreb, 10000, Croatia|Investigator Site 1106, Zagreb, 10000, Croatia|Investigator Site 1205, Znojmo, 66 902, Czechia|Investigator Site 2103, Aarhus N, 8200, Denmark|Investigator Site 2107, Fredericia, 7000, Denmark|Investigator Site 2101, Roskilde, 4000, Denmark|Investigator Site 2105, Viborg, 8800, Denmark|Investigator Site 1308, Tbilisi, 0102, Georgia|Investigator Site 1312, Tbilisi, 0144, Georgia|Investigator Site 1301, Tbilisi, 0159, Georgia|Investigator Site 1302, Tbilisi, 0159, Georgia|Investigator Site 1304, Tbilisi, 0159, Georgia|Investigator Site 1305, Tbilisi, 0159, Georgia|Investigator Site 1306, Tbilisi, 0159, Georgia|Investigator Site 1307, Tbilisi, 0159, Georgia|Investigator Site 1309, Tbilisi, 0159, Georgia|Investigator Site 1310, Tbilisi, 0159, Georgia|Investigator Site 1311, Tbilisi, 0159, Georgia|Investigator Site 1303, Tbilisi, 0186, Georgia|Investigator Site 1410, Balatonfured, H-8230, Hungary|Investigator Site 1415, Budapest, H-1133, Hungary|Investigator Site 1401, Gyor, H-9024, Hungary|Investigator Site 1406, Hatvan, H-3000, Hungary|Investigator Site 1405, Jaszbereny, H-5100, Hungary|Investigator Site 1411, Kistarcsa, H-2143, Hungary|Investigator Site 1407, Veszprem, H-8200, Hungary|Investigator Site 2201, Pavia, 27100, Italy|Investigator Site 1703, Belgrade, 11000, Serbia|Investigator Site 1710, Vrsac, 26300, Serbia|Investigator Site 1707, Zrenjanin, 23000, Serbia|Investigator Site 1802, Celje, 3000, Slovenia|Investigator Site 1803, Jesenice, 4270, Slovenia|Investigator Site 1915, Ivano-Frankivsk, 76018, Ukraine|Investigator Site 1904, Kharkiv, 61007, Ukraine|Investigator Site 1903, Kharkiv, 61018, Ukraine|Investigator Site 1908, Kharkiv, 61039, Ukraine|Investigator Site 1909, Kyiv, 04114, Ukraine|Investigator Site 1911, Kyiv, 3680, Ukraine|Investigator Site 1914, Lugansk, 91045, Ukraine|Investigator Site 1907, Zaporizhzhia, 69001, Ukraine|Investigator Site 1906, Zaporizhzhia, 69118, Ukraine
URL: https://clinicaltrials.gov/show/NCT01810939

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress