Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033317
Recruitment Status : Terminated (Study terminated due to slow enrollment)
First Posted : January 10, 2014
Results First Posted : December 15, 2015
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Vifor Pharma ( Relypsa, Inc. )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: patiromer Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Potassium
Drug Information available for: Patiromer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Serum Potassium (Day 1 to Day 8) [ Time Frame: Day 1 and Day 8 ]
  2. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033317


Locations
Layout table for location information
United States, Florida
Investigator Site
Orlando, Florida, United States, 32809
United States, Minnesota
Investigator Site
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Relypsa, Inc.
Investigators
Layout table for investigator information
Study Director: VP Clinical Development Relypsa, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT02033317    
Other Study ID Numbers: RLY5016-201
First Posted: January 10, 2014    Key Record Dates
Results First Posted: December 15, 2015
Last Update Posted: May 12, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases