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

Primary Purpose

Chronic Kidney Disease (CKD), Hyperkalemia (HK)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Patiromer
Placebo
Sponsored by
Relypsa, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease (CKD) focused on measuring Chronic Kidney Disease, Treatment of Hyperkalemia, Hyperkalemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site 3121
  • Investigator Site 3133
  • Investigator Site 3103
  • Investigator Site 3129
  • Investigator Site 3130
  • Investigator Site 3105
  • Investigator Site 3113
  • Investigator Site 3106
  • Investigator Site 3120
  • Investigator Site 3102
  • Investigator Site 3104
  • Investigator Site 3134
  • Investigator Site 3107
  • Investigator Site 3110
  • Investigator Site 1103
  • Investigator Site 1102
  • Investigator Site 1104
  • Investigator Site 1105
  • Investigator Site 1106
  • Investigator Site 1205
  • Investigator Site 2103
  • Investigator Site 2107
  • Investigator Site 2101
  • Investigator Site 2105
  • Investigator Site 1308
  • Investigator Site 1312
  • Investigator Site 1301
  • Investigator Site 1302
  • Investigator Site 1304
  • Investigator Site 1305
  • Investigator Site 1306
  • Investigator Site 1307
  • Investigator Site 1309
  • Investigator Site 1310
  • Investigator Site 1311
  • Investigator Site 1303
  • Investigator Site 1410
  • Investigator Site 1415
  • Investigator Site 1401
  • Investigator Site 1406
  • Investigator Site 1405
  • Investigator Site 1411
  • Investigator Site 1407
  • Investigator Site 2201
  • Investigator Site 1703
  • Investigator Site 1710
  • Investigator Site 1707
  • Investigator Site 1802
  • Investigator Site 1803
  • Investigator Site 1915
  • Investigator Site 1904
  • Investigator Site 1903
  • Investigator Site 1908
  • Investigator Site 1909
  • Investigator Site 1911
  • Investigator Site 1914
  • Investigator Site 1907
  • Investigator Site 1906

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patiromer

Placebo

Arm Description

Patiromer was administered twice a day as a powder mixed with water.

Placebo was administered twice a day as a powder mixed with water.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4
Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B
Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B

Full Information

First Posted
March 12, 2013
Last Updated
May 10, 2021
Sponsor
Relypsa, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01810939
Brief Title
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
Acronym
OPAL
Official Title
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relypsa, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease (CKD), Hyperkalemia (HK)
Keywords
Chronic Kidney Disease, Treatment of Hyperkalemia, Hyperkalemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patiromer
Arm Type
Active Comparator
Arm Description
Patiromer was administered twice a day as a powder mixed with water.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was administered twice a day as a powder mixed with water.
Intervention Type
Drug
Intervention Name(s)
Patiromer
Other Intervention Name(s)
RLY5016 for Oral Suspension, Veltassa
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Serum Potassium From Part A Baseline to Part A Week 4
Description
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).
Time Frame
Part A Baseline to Part A Week 4
Title
Change in Serum Potassium From Part B Baseline
Description
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.
Time Frame
Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L
Secondary Outcome Measure Information:
Title
Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4
Time Frame
Week 4
Title
Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B
Time Frame
Part B Baseline to Part B Week 8
Title
Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B
Time Frame
Part B Baseline to Part B Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director Clinical Operations
Organizational Affiliation
Relypsa, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 3121
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Investigator Site 3133
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Investigator Site 3103
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Investigator Site 3129
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
Investigator Site 3130
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Investigator Site 3105
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Investigator Site 3113
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigator Site 3106
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigator Site 3120
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Investigator Site 3102
City
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Facility Name
Investigator Site 3104
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Investigator Site 3134
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Investigator Site 3107
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Investigator Site 3110
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigator Site 1103
City
Karlovac
ZIP/Postal Code
47000
Country
Croatia
Facility Name
Investigator Site 1102
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Investigator Site 1104
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigator Site 1105
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigator Site 1106
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigator Site 1205
City
Znojmo
ZIP/Postal Code
66 902
Country
Czechia
Facility Name
Investigator Site 2103
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Investigator Site 2107
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Facility Name
Investigator Site 2101
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Investigator Site 2105
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Investigator Site 1308
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Investigator Site 1312
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Investigator Site 1301
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1302
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1304
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1305
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1306
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1307
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1309
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1310
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1311
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 1303
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Investigator Site 1410
City
Balatonfured
ZIP/Postal Code
H-8230
Country
Hungary
Facility Name
Investigator Site 1415
City
Budapest
ZIP/Postal Code
H-1133
Country
Hungary
Facility Name
Investigator Site 1401
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Investigator Site 1406
City
Hatvan
ZIP/Postal Code
H-3000
Country
Hungary
Facility Name
Investigator Site 1405
City
Jaszbereny
ZIP/Postal Code
H-5100
Country
Hungary
Facility Name
Investigator Site 1411
City
Kistarcsa
ZIP/Postal Code
H-2143
Country
Hungary
Facility Name
Investigator Site 1407
City
Veszprem
ZIP/Postal Code
H-8200
Country
Hungary
Facility Name
Investigator Site 2201
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Investigator Site 1703
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigator Site 1710
City
Vrsac
ZIP/Postal Code
26300
Country
Serbia
Facility Name
Investigator Site 1707
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Investigator Site 1802
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Facility Name
Investigator Site 1803
City
Jesenice
ZIP/Postal Code
4270
Country
Slovenia
Facility Name
Investigator Site 1915
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigator Site 1904
City
Kharkiv
ZIP/Postal Code
61007
Country
Ukraine
Facility Name
Investigator Site 1903
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Investigator Site 1908
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Investigator Site 1909
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Investigator Site 1911
City
Kyiv
ZIP/Postal Code
3680
Country
Ukraine
Facility Name
Investigator Site 1914
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Investigator Site 1907
City
Zaporizhzhia
ZIP/Postal Code
69001
Country
Ukraine
Facility Name
Investigator Site 1906
City
Zaporizhzhia
ZIP/Postal Code
69118
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25415805
Citation
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.
Results Reference
background
PubMed Identifier
32588430
Citation
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.
Results Reference
derived
Links:
URL
http://www.relypsa.com
Description
Relypsa company website

Learn more about this trial

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

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