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

NCT01810939 | Completed Phase 3 Results

• 2 other identifiers: RLY5016-3012012-001956-20
• Study Type: interventional
• Target: 243
• Locations: 10 countries
• Sites: 58

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.

Conditions

Chronic Kidney Disease (CKD); Hyperkalemia (HK)

Keywords

Chronic Kidney Disease; Treatment of Hyperkalemia; Hyperkalemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Patiromer

ACTIVE COMPARATOR

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

Drug: Patiromer

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Patiromer DRUG

Also known as: RLY5016 for Oral Suspension, Veltassa

Patiromer

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Relypsa, Inc.: lead

Study Sites (58)

Investigator Site 3121

Azusa, California, 91702, United States

Location

Investigator Site 3133

Los Angeles, California, 90025, United States

Location

Investigator Site 3103

Sacramento, California, 95825, United States

Location

Investigator Site 3129

Santa Barbara, California, 93110, United States

Location

Investigator Site 3130

Ventura, California, 93003, United States

Location

Investigator Site 3105

Edgewater, Florida, 32132, United States

Location

Investigator Site 3113

Hollywood, Florida, 33021, United States

Location

Investigator Site 3106

Port Charlotte, Florida, 33952, United States

Location

Investigator Site 3120

Augusta, Georgia, 30909, United States

Location

Investigator Site 3102

Farmington, Missouri, 63640, United States

Location

Investigator Site 3104

Kansas City, Missouri, 64111, United States

Location

Investigator Site 3134

Flushing, New York, 11355, United States

Location

Investigator Site 3107

Bethlehem, Pennsylvania, 18017, United States

Location

Investigator Site 3110

San Antonio, Texas, 78229, United States

Location

Investigator Site 1103

Karlovac, 47000, Croatia

Location

Investigator Site 1102

Osijek, 31000, Croatia

Location

Investigator Site 1104

Zagreb, 10000, Croatia

Location

Investigator Site 1105

Zagreb, 10000, Croatia

Location

Investigator Site 1106

Zagreb, 10000, Croatia

Location

Investigator Site 1205

Znojmo, 66 902, Czechia

Location

Investigator Site 2103

Aarhus N, 8200, Denmark

Location

Investigator Site 2107

Fredericia, 7000, Denmark

Location

Investigator Site 2101

Roskilde, 4000, Denmark

Location

Investigator Site 2105

Viborg, 8800, Denmark

Location

Investigator Site 1308

Tbilisi, 0102, Georgia

Location

Investigator Site 1312

Tbilisi, 0144, Georgia

Location

Investigator Site 1301

Tbilisi, 0159, Georgia

Location

Investigator Site 1302

Tbilisi, 0159, Georgia

Location

Investigator Site 1304

Tbilisi, 0159, Georgia

Location

Investigator Site 1305

Tbilisi, 0159, Georgia

Location

Investigator Site 1306

Tbilisi, 0159, Georgia

Location

Investigator Site 1307

Tbilisi, 0159, Georgia

Location

Investigator Site 1309

Tbilisi, 0159, Georgia

Location

Investigator Site 1310

Tbilisi, 0159, Georgia

Location

Investigator Site 1311

Tbilisi, 0159, Georgia

Location

Investigator Site 1303

Tbilisi, 0186, Georgia

Location

Investigator Site 1410

Balatonfüred, H-8230, Hungary

Location

Investigator Site 1415

Budapest, H-1133, Hungary

Location

Investigator Site 1401

Győr, H-9024, Hungary

Location

Investigator Site 1406

Hatvan, H-3000, Hungary

Location

Investigator Site 1405

Jászberény, H-5100, Hungary

Location

Investigator Site 1411

Kistarcsa, H-2143, Hungary

Location

Investigator Site 1407

Veszprém, H-8200, Hungary

Location

Investigator Site 2201

Pavia, 27100, Italy

Location

Investigator Site 1703

Belgrade, 11000, Serbia

Location

Investigator Site 1710

Vršac, 26300, Serbia

Location

Investigator Site 1707

Zrenjanin, 23000, Serbia

Location

Investigator Site 1802

Celje, 3000, Slovenia

Location

Investigator Site 1803

Jesenice, 4270, Slovenia

Location

Investigator Site 1915

Ivano-Frankivsk, 76018, Ukraine

Location

Investigator Site 1904

Kharkiv, 61007, Ukraine

Location

Investigator Site 1903

Kharkiv, 61018, Ukraine

Location

Investigator Site 1908

Kharkiv, 61039, Ukraine

Location

Investigator Site 1909

Kyiv, 04114, Ukraine

Location

Investigator Site 1911

Kyiv, 3680, Ukraine

Location

Investigator Site 1914

Luhansk, 91045, Ukraine

Location

Investigator Site 1907

Zaporizhzhia, 69001, Ukraine

Location

Investigator Site 1906

Zaporizhzhia, 69118, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 25415805 BACKGROUND

• 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.

  PMID: 32588430 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Interventions

patiromer; Suspensions

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Information
• Organization: Relypsa, Inc.

medinfo@relypsa.com

1-844-relypsa

Study Officials

• Director Clinical Operations

  Relypsa, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 3, 2021
• Results First Posted: December 15, 2015

Record last verified: 2021-05

Locations

DK (4); US (14); IT (1); SL (2); HU (7); UA (9); CR (5); SE (3); GE (12); CZ (1)