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NCT02033317 Clinical Trial

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

Hyperkalemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02033317
Other study ID # RLY5016-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 2008
Est. completion date December 2008

Study information
Verified date May 2021
Source Vifor Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• patiromer
15 grams/day (5 grams 3 times daily) administered orally

Locations
Country Name City State
United States Investigator Site Minneapolis Minnesota
United States Investigator Site Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
Relypsa, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Serum Potassium (Day 1 to Day 8) Day 1 and Day 8
Primary 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
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