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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. )

Tracking Information
First Submitted Date  ICMJE February 25, 2016
First Posted Date  ICMJE February 29, 2016
Results First Submitted Date  ICMJE July 11, 2017
Results First Posted Date  ICMJE November 20, 2017
Last Update Posted Date May 12, 2021
Study Start Date  ICMJE February 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
Proportion of Participants with Either Week 3 or Week 4 Serum Potassium in Target Range (3.8 - 5.0 mEq/L) [ Time Frame: 21 to 28 Days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
Mean Change from Baseline to Week 4 in Serum Potassium [ Time Frame: Baseline and Day 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patiromer With or Without Food for the Treatment of Hyperkalemia
Official Title  ICMJE 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)
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperkalemia
Intervention  ICMJE Drug: patiromer
8.4 g/day starting dose, administered orally
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension
Study Arms  ICMJE
  • Experimental: Group 1 - Dosing Without Food
    Patiromer dosing without food
    Intervention: Drug: patiromer
  • Active Comparator: Group 2 - Dosing With Food
    Patiromer dosing with food
    Intervention: Drug: patiromer
Publications * Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6:CD013165. doi: 10.1002/14651858.CD013165.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2016)
114
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2016)
110
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02694744
Other Study ID Numbers  ICMJE RLY5016-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vifor Pharma ( Relypsa, Inc. )
Study Sponsor  ICMJE Relypsa, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director or VP Clinical Development Relypsa, Inc.
PRS Account Vifor Pharma
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP