Patiromer With or Without Food for the Treatment of Hyperkalemia

Relypsa, Inc.114 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Hyperkalemia

Interventions

patiromerDRUG

8.4 g/day starting dose, administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Potassium concentration \> 5.0 mEq/L from two blood draws at Screening * Stable RAASi medication, if taking * Medications taken on a chronic basis are given once daily or twice daily * Informed consent given Key Exclusion Criteria: * Expected need for dialysis * Major organ transplant * History of conditions associated with pseudohyperkalemia * History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery * Cancer or unstable medical condition

Locations (29)

Outcomes

Primary Outcomes

Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4

Time frame: 21 to 28 Days

Secondary Outcomes

Mean Change in Serum Potassium From Baseline to Week 4

An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.

Time frame: Baseline to Day 28

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.