Clinical Trial: Patiromer With or Without Food for the Treatment of Hyperkalemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of patiromer (the investigational medication) administered once daily (QD) when given with food compared to without food for the treatment of hyperkalemia (high potassium in the blood).

Detailed Summary:

Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4 g/day, either with or without food.

All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.

The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Sponsor: Relypsa, Inc.

Current Primary Outcome: Proportion of Participants with Either Week 3 or Week 4 Serum Potassium in Target Range (3.8 - 5.0 mEq/L) [ Time Frame: 21 to 28 Days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Mean Change from Baseline to Week 4 in Serum Potassium [ Time Frame: Baseline and Day 28 ]

Original Secondary Outcome: Same as current

Information By: Relypsa, Inc.

Dates:
Date Received: February 25, 2016
Date Started: February 2016
Date Completion:
Last Updated: September 22, 2016
Last Verified: September 2016