Patiromer With or Without Food for the Treatment of Hyperkalemia
TOURMALINE
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)
1 other identifier
interventional
114
1 country
29
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2016
Shorter than P25 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
November 20, 2017
CompletedMay 12, 2021
May 1, 2021
5 months
February 25, 2016
July 11, 2017
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
21 to 28 Days
Secondary Outcomes (1)
Mean Change in Serum Potassium From Baseline to Week 4
Baseline to Day 28
Study Arms (2)
Group 1 - Dosing Without Food
EXPERIMENTALPatiromer dosing without food
Group 2 - Dosing With Food
ACTIVE COMPARATORPatiromer dosing with food
Interventions
8.4 g/day starting dose, administered orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Relypsa, Inc.lead
Study Sites (29)
Investigator Site 12
Fountain Valley, California, 92708, United States
Investigator Site 11
Huntington Beach, California, 92648, United States
Investigator Site 38
Palm Springs, California, 92262, United States
Investigator Site 20
Riverside, California, 92505, United States
Investigator Site 21
San Dimas, California, 91773, United States
Investigator Site 24
Denver, Colorado, 80230, United States
Investigator Site 30
Edgewater, Florida, 32132, United States
Investigator Site 10
Hialeah, Florida, 33012, United States
Investigator Site 13
Hollywood, Florida, 33021, United States
Investigator Site 17
Lauderdale Lakes, Florida, 33313-1638, United States
Investigator Site 16
Lauderdale Lakes, Florida, 33319, United States
Investigator Site 15
Miami, Florida, 33015, United States
Investigator Site 43
Miami, Florida, 33147, United States
Investigator Site 18
Pembroke Pines, Florida, 33028, United States
Investigator Site 27
Tampa, Florida, 33614, United States
Investigator Site 44
Meridian, Idaho, 83642, United States
Investigator Site 39
Aurora, Illinois, 60504, United States
Investigator Site 23
Flint, Michigan, 48504, United States
Investigator Site 34
Kansas City, Missouri, 64111, United States
Investigator Site 41
Las Vegas, Nevada, 89106, United States
Investigator Site 37
Flushing, New York, 11355, United States
Investigator Site 36
Norman, Oklahoma, 73069, United States
Investigator Site 40
Jackson, Tennessee, 38305, United States
Investigator Site 33
Dallas, Texas, 75231, United States
Investigator Site 26
San Antonio, Texas, 78202, United States
Investigator Site 29
San Antonio, Texas, 78207, United States
Investigator Site 28
San Antonio, Texas, 78215, United States
Investigator Site 25
San Antonio, Texas, 78229, United States
Investigator Site 22
Salt Lake City, Utah, 84124, United States
Related Publications (1)
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(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
PMID: 32588430DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information
- Organization
- Relypsa, Inc.
Study Officials
- STUDY DIRECTOR
Study Director or VP Clinical Development
Relypsa, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
February 29, 2016
Study Start
February 1, 2016
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
May 12, 2021
Results First Posted
November 20, 2017
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share