Study Stopped
Study terminated due to slow enrollment
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
1 other identifier
interventional
6
1 country
2
Brief Summary
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedResults Posted
Study results publicly available
December 15, 2015
CompletedMay 12, 2021
May 1, 2021
4 months
January 9, 2014
November 11, 2015
May 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
patiromer
EXPERIMENTALInterventions
15 grams/day (5 grams 3 times daily) administered orally
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Relypsa, Inc.lead
Study Sites (2)
Investigator Site
Orlando, Florida, 32809, United States
Investigator Site
Minneapolis, Minnesota, 55404, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Medical Information
- Organization
- Relypsa, Inc.
Study Officials
- STUDY DIRECTOR
VP Clinical Development
Relypsa, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 10, 2014
Study Start
August 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
May 12, 2021
Results First Posted
December 15, 2015
Record last verified: 2021-05