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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01810939
• Date of registration: 12/03/2013
• Prospective Registration: No
• Primary sponsor: Relypsa, Inc.
• Public title: A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL) OPAL
• Scientific title: A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
• Date of first enrolment: February 2013
• Target sample size: 243
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01810939
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Bulgaria, Croatia, Czech Republic, Denmark, Georgia, Hungary, Italy, Serbia, Slovenia, Ukraine, United States

Contacts

• Name: Director Clinical Operations
• Affiliation: Relypsa, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease (CKD)

Hyperkalemia (HK)

Intervention(s)

Drug: Patiromer

Drug: Placebo

Primary Outcome(s)

Change in Serum Potassium From Part A Baseline to Part A Week 4 [Time Frame: Part A Baseline to Part A Week 4]

Change in Serum Potassium From Part B Baseline [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(s)

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]

Proportion of Participants With Serum Potassium = 5.1 mEq/L in Part B [Time Frame: Part B Baseline to Part B Week 8]

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]

Secondary ID(s)

2012-001956-20

RLY5016-301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01810939