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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 : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Relypsa, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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

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




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 ]


Information from the National Library of Medicine

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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.

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
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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
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Study Director: VP Clinical Development Relypsa, Inc.

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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: February 25, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases