An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
NCT ID: NCT02033317
Last Updated: 2021-05-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2008-08-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patiromer
patiromer
15 grams/day (5 grams 3 times daily) administered orally
Interventions
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patiromer
15 grams/day (5 grams 3 times daily) administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequately dialyzed (Kt/V ≥ 1.2)
Exclusion Criteria
* Severe constipation or irregular bowel habits.
* Unable to consume or tolerate the study-specific diet.
18 Years
70 Years
ALL
No
Sponsors
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Relypsa, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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VP Clinical Development
Role: STUDY_DIRECTOR
Relypsa, Inc.
Locations
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Investigator Site
Orlando, Florida, United States
Investigator Site
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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RLY5016-201
Identifier Type: -
Identifier Source: org_study_id
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