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

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

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

Study Overview

• Status: Terminated
• Conditions: Hyperkalemia
• Intervention / Treatment: Drug: patiromer

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Investigator Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patiromer	Drug: patiromer; 15 grams/day (5 grams 3 times daily) administered orally; Other Names: Veltassa; RLY5016 for Oral Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Serum Potassium (Day 1 to Day 8)	Day 1 and Day 8
Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)	Day -7 Through Day -1 and Day 1 Through Day 7

Collaborators and Investigators

• Sponsor: Relypsa, Inc.
• Investigators: Study Director: VP Clinical Development, Relypsa, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: RLY5016-201