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Patiromer With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

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: NCT02694744
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : November 20, 2017
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Vifor Pharma ( Relypsa, Inc. )

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: patiromer Phase 4

Detailed Description:

Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.

All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.

The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)
Study Start Date : February 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
Drug Information available for: Patiromer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1 - Dosing Without Food
Patiromer dosing without food
 Drug: patiromer
8.4 g/day starting dose, administered orally
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension
Active Comparator: Group 2 - Dosing With Food
Patiromer dosing with food
 Drug: patiromer
8.4 g/day starting dose, administered orally
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 [ Time Frame: 21 to 28 Days ]

Secondary Outcome Measures :
  1. Mean Change in Serum Potassium From Baseline to Week 4 [ Time Frame: Baseline to Day 28 ]
    An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Potassium concentration > 5.0 mEq/L from two blood draws at Screening
  • Stable RAASi medication, if taking
  • Medications taken on a chronic basis are given once daily or twice daily
  • Informed consent given

Key Exclusion Criteria:

  • Expected need for dialysis
  • Major organ transplant
  • History of conditions associated with pseudohyperkalemia
  • History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
  • Cancer or unstable medical condition
Contacts and Locations
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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): NCT02694744


Locations
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Sponsors and Collaborators
Relypsa, Inc.
Investigators
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Study Director: Study Director or VP Clinical Development Relypsa, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT02694744    
Other Study ID Numbers: RLY5016-401
First Posted: February 29, 2016    Key Record Dates
Results First Posted: November 20, 2017
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vifor Pharma ( Relypsa, Inc. ):
Treatment of Hyperkalemia
Hyperkalemia
Potassium
Chronic Kidney Disease
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases