An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

Relypsa

Status and phase

Terminated

Phase 2

Conditions

Hyperkalemia

Treatments

Drug: patiromer

Study type

Interventional

Funder types

Industry

Identifiers

NCT02033317

RLY5016-201

Details and patient eligibility

About

This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Full description

The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.

This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Enrollment

6 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L
Adequately dialyzed (Kt/V ≥ 1.2)

Exclusion criteria

History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery.
Severe constipation or irregular bowel habits.
Unable to consume or tolerate the study-specific diet.