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NCT02694744 Clinical Trial

Patiromer With or Without Food for the Treatment of Hyperkalemia

Hyperkalemia Clinical Trial

— TOURMALINE  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02694744
Other study ID # RLY5016-401
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2016
Est. completion date August 2016

Study information
Verified date May 2021
Source Vifor Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• patiromer
8.4 g/day starting dose, administered orally

Locations
Country Name City State
United States Investigator Site 39 Aurora Illinois
United States Investigator Site 33 Dallas Texas
United States Investigator Site 24 Denver Colorado
United States Investigator Site 30 Edgewater Florida
United States Investigator Site 23 Flint Michigan
United States Investigator Site 37 Flushing New York
United States Investigator Site 12 Fountain Valley California
United States Investigator Site 10 Hialeah Florida
United States Investigator Site 13 Hollywood Florida
United States Investigator Site 11 Huntington Beach California
United States Investigator Site 40 Jackson Tennessee
United States Investigator Site 34 Kansas City Missouri
United States Investigator Site 41 Las Vegas Nevada
United States Investigator Site 16 Lauderdale Lakes Florida
United States Investigator Site 17 Lauderdale Lakes Florida
United States Investigator Site 44 Meridian Idaho
United States Investigator Site 15 Miami Florida
United States Investigator Site 43 Miami Florida
United States Investigator Site 36 Norman Oklahoma
United States Investigator Site 38 Palm Springs California
United States Investigator Site 18 Pembroke Pines Florida
United States Investigator Site 20 Riverside California
United States Investigator Site 22 Salt Lake City Utah
United States Investigator Site 25 San Antonio Texas
United States Investigator Site 26 San Antonio Texas
United States Investigator Site 28 San Antonio Texas
United States Investigator Site 29 San Antonio Texas
United States Investigator Site 21 San Dimas California
United States Investigator Site 27 Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Relypsa, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Mean Change in Serum Potassium From Baseline to Week 4 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. Baseline to Day 28
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