A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

Chronic Kidney Disease (CKD) Clinical Trial

— OPAL  

Official title:

A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810939
• Other study ID #: RLY5016-301
• Secondary ID: 2012-001956-20
• Status: Completed
• Phase: Phase 3
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: May 2021
• Source: Vifor Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.

Description:

There were two parts in the study, Part A and Part B. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males and females ages 18 - 80
• 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 auto-immune related chronic kidney disease such as lupus nephritis or renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Hyperkalemia
• Hyperkalemia (HK)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Patiromer

• Placebo

Locations

Country	Name	City	State
Croatia	Investigator Site 1103	Karlovac
Croatia	Investigator Site 1102	Osijek
Croatia	Investigator Site 1104	Zagreb
Croatia	Investigator Site 1105	Zagreb
Croatia	Investigator Site 1106	Zagreb
Czechia	Investigator Site 1205	Znojmo
Denmark	Investigator Site 2103	Aarhus N
Denmark	Investigator Site 2107	Fredericia
Denmark	Investigator Site 2101	Roskilde
Denmark	Investigator Site 2105	Viborg
Georgia	Investigator Site 1301	Tbilisi
Georgia	Investigator Site 1302	Tbilisi
Georgia	Investigator Site 1303	Tbilisi
Georgia	Investigator Site 1304	Tbilisi
Georgia	Investigator Site 1305	Tbilisi
Georgia	Investigator Site 1306	Tbilisi
Georgia	Investigator Site 1307	Tbilisi
Georgia	Investigator Site 1308	Tbilisi
Georgia	Investigator Site 1309	Tbilisi
Georgia	Investigator Site 1310	Tbilisi
Georgia	Investigator Site 1311	Tbilisi
Georgia	Investigator Site 1312	Tbilisi
Hungary	Investigator Site 1410	Balatonfured
Hungary	Investigator Site 1415	Budapest
Hungary	Investigator Site 1401	Gyor
Hungary	Investigator Site 1406	Hatvan
Hungary	Investigator Site 1405	Jaszbereny
Hungary	Investigator Site 1411	Kistarcsa
Hungary	Investigator Site 1407	Veszprem
Italy	Investigator Site 2201	Pavia
Serbia	Investigator Site 1703	Belgrade
Serbia	Investigator Site 1710	Vrsac
Serbia	Investigator Site 1707	Zrenjanin
Slovenia	Investigator Site 1802	Celje
Slovenia	Investigator Site 1803	Jesenice
Ukraine	Investigator Site 1915	Ivano-Frankivsk
Ukraine	Investigator Site 1903	Kharkiv
Ukraine	Investigator Site 1904	Kharkiv
Ukraine	Investigator Site 1908	Kharkiv
Ukraine	Investigator Site 1909	Kyiv
Ukraine	Investigator Site 1911	Kyiv
Ukraine	Investigator Site 1914	Lugansk
Ukraine	Investigator Site 1906	Zaporizhzhia
Ukraine	Investigator Site 1907	Zaporizhzhia
United States	Investigator Site 3120	Augusta	Georgia
United States	Investigator Site 3121	Azusa	California
United States	Investigator Site 3107	Bethlehem	Pennsylvania
United States	Investigator Site 3105	Edgewater	Florida
United States	Investigator Site 3102	Farmington	Missouri
United States	Investigator Site 3134	Flushing	New York
United States	Investigator Site 3113	Hollywood	Florida
United States	Investigator Site 3104	Kansas City	Missouri
United States	Investigator Site 3133	Los Angeles	California
United States	Investigator Site 3106	Port Charlotte	Florida
United States	Investigator Site 3103	Sacramento	California
United States	Investigator Site 3110	San Antonio	Texas
United States	Investigator Site 3129	Santa Barbara	California
United States	Investigator Site 3130	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Relypsa, Inc.

Countries where clinical trial is conducted

United States,  Croatia,  Czechia,  Denmark,  Georgia,  Hungary,  Italy,  Serbia,  Slovenia,  Ukraine, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Primary	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
Secondary	Proportion of Participants With Serum Potassium That Was = 5.5 mEq/L in Part B		Part B Baseline to Part B Week 8
Secondary	Proportion of Participants With Serum Potassium = 5.1 mEq/L in Part B		Part B Baseline to Part B Week 8

External Links

•   Relypsa company website