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

May 10, 2021 updated by: Relypsa, Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Day 1 and 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)
Time Frame: Day -7 Through Day -1 and Day 1 Through Day 7
Day -7 Through Day -1 and Day 1 Through Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Relypsa, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • RLY5016-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe