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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02694744
First Posted: February 29, 2016
Last Update Posted: November 20, 2017
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.
Information provided by (Responsible Party):
Relypsa, Inc.
  Purpose
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 Intervention Phase
Hyperkalemia Drug: patiromer Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Relypsa, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 114
Study Start Date: February 2016
Study Completion Date: August 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 29 Study Locations
Sponsors and Collaborators
Relypsa, Inc.
Investigators
Study Director: Study Director or VP Clinical Development Relypsa, Inc.
  More Information

Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT02694744     History of Changes
Other Study ID Numbers: RLY5016-401
First Submitted: February 25, 2016
First Posted: February 29, 2016
Results First Submitted: July 11, 2017
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Relypsa, Inc.:
Treatment of Hyperkalemia
Hyperkalemia
Potassium
Chronic Kidney Disease

Additional relevant MeSH terms:
Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases