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

Part of paid clinical trials in Azusa, California.

Sponsor
Relypsa, Inc.
Study ID
NCT01810939
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Kidney Disease (CKD)
  • Hyperkalemia (HK)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 28, 2013
Status verified
May 2021
Primary completion
Jul 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
243 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Patiromer
    Patiromer was administered twice a day as a powder mixed with water.
  • Placebo Comparator: Placebo
    Placebo was administered twice a day as a powder mixed with water.

Primary Outcome Measure

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

Locations (14)

FacilityCityStateZIPSite coordinators
Investigator Site 3121AzusaCalifornia91702-
Investigator Site 3133Los AngelesCalifornia90025-
Investigator Site 3103SacramentoCalifornia95825-
Investigator Site 3129Santa BarbaraCalifornia93110-
Investigator Site 3130VenturaCalifornia93003-
Investigator Site 3105EdgewaterFlorida32132-
Investigator Site 3113HollywoodFlorida33021-
Investigator Site 3106Port CharlotteFlorida33952-
Investigator Site 3120AugustaGeorgia30909-
Investigator Site 3102FarmingtonMissouri63640-
Investigator Site 3104Kansas CityMissouri64111-
Investigator Site 3134FlushingNew York11355-
Investigator Site 3107BethlehemPennsylvania18017-
Investigator Site 3110San AntonioTexas78229-

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