A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
NCT ID: NCT01810939
Last Updated: 2021-06-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
243 participants
INTERVENTIONAL
2013-02-28
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
NCT02033317
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
NCT03183778
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
NCT03087058
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
NCT03781089
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
NCT04780841
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.
All participants received patiromer during Part A; Part B participants were randomized to continue patiromer or switch to placebo. Total study participation was up to 14 weeks (including up to 2 weeks of follow up).
The dose of patiromer could be titrated based on participant's serum potassium response.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patiromer
Patiromer was administered twice a day as a powder mixed with water.
Patiromer
Placebo
Placebo was administered twice a day as a powder mixed with water.
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Patiromer
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic kidney disease (CKD) - eGFR 15 to \< 60 mL/min/1.73m2 at screening
* Hyperkalemia, defined as a serum potassium value of 5.1 to \< 6.5 mEq/L at screening
* Taking either an Angiotensin-Converting Enzyme (ACE) Inhibitor, an Angiotensin II receptor blocker (ARB), or an aldosterone antagonist (AA) medication
* Informed consent given
Exclusion Criteria
* Participants with uncontrolled Type 1 diabetes, defined as or a HbA1c \> 10.0 %, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the previous 6 months in participants with Type 2 diabetes
* Participants with severe heart failure, defined as NYHA (New York Heart Association) class IV
* Participants with major surgery including thoracic and cardiac, in the past 3 months, or participants with heart or kidney transplant
* Participants with significant cardiovascular or cerebrovascular events in the past 2 months, such as cardiac arrest, myocardial infarction, or stroke
* Participants with BMI ≥ 40 kg/m2
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Relypsa, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Director Clinical Operations
Role: STUDY_DIRECTOR
Relypsa, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigator Site 3121
Azusa, California, United States
Investigator Site 3133
Los Angeles, California, United States
Investigator Site 3103
Sacramento, California, United States
Investigator Site 3129
Santa Barbara, California, United States
Investigator Site 3130
Ventura, California, United States
Investigator Site 3105
Edgewater, Florida, United States
Investigator Site 3113
Hollywood, Florida, United States
Investigator Site 3106
Port Charlotte, Florida, United States
Investigator Site 3120
Augusta, Georgia, United States
Investigator Site 3102
Farmington, Missouri, United States
Investigator Site 3104
Kansas City, Missouri, United States
Investigator Site 3134
Flushing, New York, United States
Investigator Site 3107
Bethlehem, Pennsylvania, United States
Investigator Site 3110
San Antonio, Texas, United States
Investigator Site 1103
Karlovac, , Croatia
Investigator Site 1102
Osijek, , Croatia
Investigator Site 1104
Zagreb, , Croatia
Investigator Site 1105
Zagreb, , Croatia
Investigator Site 1106
Zagreb, , Croatia
Investigator Site 1205
Znojmo, , Czechia
Investigator Site 2103
Aarhus N, , Denmark
Investigator Site 2107
Fredericia, , Denmark
Investigator Site 2101
Roskilde, , Denmark
Investigator Site 2105
Viborg, , Denmark
Investigator Site 1308
Tbilisi, , Georgia
Investigator Site 1312
Tbilisi, , Georgia
Investigator Site 1301
Tbilisi, , Georgia
Investigator Site 1302
Tbilisi, , Georgia
Investigator Site 1304
Tbilisi, , Georgia
Investigator Site 1305
Tbilisi, , Georgia
Investigator Site 1306
Tbilisi, , Georgia
Investigator Site 1307
Tbilisi, , Georgia
Investigator Site 1309
Tbilisi, , Georgia
Investigator Site 1310
Tbilisi, , Georgia
Investigator Site 1311
Tbilisi, , Georgia
Investigator Site 1303
Tbilisi, , Georgia
Investigator Site 1410
Balatonfüred, , Hungary
Investigator Site 1415
Budapest, , Hungary
Investigator Site 1401
Győr, , Hungary
Investigator Site 1406
Hatvan, , Hungary
Investigator Site 1405
Jászberény, , Hungary
Investigator Site 1411
Kistarcsa, , Hungary
Investigator Site 1407
Veszprém, , Hungary
Investigator Site 2201
Pavia, , Italy
Investigator Site 1703
Belgrade, , Serbia
Investigator Site 1710
Vršac, , Serbia
Investigator Site 1707
Zrenjanin, , Serbia
Investigator Site 1802
Celje, , Slovenia
Investigator Site 1803
Jesenice, , Slovenia
Investigator Site 1915
Ivano-Frankivsk, , Ukraine
Investigator Site 1904
Kharkiv, , Ukraine
Investigator Site 1903
Kharkiv, , Ukraine
Investigator Site 1908
Kharkiv, , Ukraine
Investigator Site 1909
Kyiv, , Ukraine
Investigator Site 1911
Kyiv, , Ukraine
Investigator Site 1914
Luhansk, , Ukraine
Investigator Site 1907
Zaporizhzhia, , Ukraine
Investigator Site 1906
Zaporizhzhia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Weir MR, Bakris GL, Bushinsky DA, Mayo MR, Garza D, Stasiv Y, Wittes J, Christ-Schmidt H, Berman L, Pitt B; OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015 Jan 15;372(3):211-21. doi: 10.1056/NEJMoa1410853. Epub 2014 Nov 21.
Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001956-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RLY5016-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.