Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease

Sponsor
Relypsa, Inc.
Study ID
NCT01130597
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • patiromer — DRUG
    Active investigational drug
  • spironolactone — DRUG

Study Details

The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).

Key Dates

Start date
May 31, 2010
Status verified
Dec 2015
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

Enrollment
63 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: patiromer
    spironolactone + patiromer

Primary Outcome Measure

Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment [ Time Frame: 56 days ]

Related Studies