Clinical trial NCT02694744: Patiromer With or Without Food for the Treatment of Hyperkalemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperkalemia
Keywords: Treatment of Hyperkalemia
Hyperkalemia
Potassium
Chronic Kidney Disease
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2016-02-29
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
timeFrame: 21 to 28 Days
Secondary outcomes:
measure: Mean Change in Serum Potassium From Baseline to Week 4
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Investigator Site 12
state: California
city: Huntington Beach
country: United States
facility: Investigator Site 11
state: California
city: Palm Springs
country: United States
facility: Investigator Site 38
state: California
city: Riverside
country: United States
facility: Investigator Site 20
state: California
city: San Dimas
country: United States
facility: Investigator Site 21
state: California
city: Denver
country: United States
facility: Investigator Site 24
state: Colorado
city: Edgewater
country: United States
facility: Investigator Site 30
state: Florida
city: Hialeah
country: United States
facility: Investigator Site 10
state: Florida
city: Hollywood
country: United States
facility: Investigator Site 13
state: Florida
city: Lauderdale Lakes
country: United States
facility: Investigator Site 17
state: Florida
city: Lauderdale Lakes
country: United States
facility: Investigator Site 16
state: Florida
city: Miami
country: United States
facility: Investigator Site 15
state: Florida
city: Miami
country: United States
facility: Investigator Site 43
state: Florida
city: Pembroke Pines
country: United States
facility: Investigator Site 18
state: Florida
city: Tampa
country: United States
facility: Investigator Site 27
state: Florida
city: Meridian
country: United States
facility: Investigator Site 44
state: Idaho
city: Aurora
country: United States
facility: Investigator Site 39
state: Illinois
city: Flint
country: United States
facility: Investigator Site 23
state: Michigan
city: Kansas City
country: United States
facility: Investigator Site 34
state: Missouri
city: Las Vegas
country: United States
facility: Investigator Site 41
state: Nevada
city: Flushing
country: United States
facility: Investigator Site 37
state: New York
city: Norman
country: United States
facility: Investigator Site 36
state: Oklahoma
city: Jackson
country: United States
facility: Investigator Site 40
state: Tennessee
city: Dallas
country: United States
facility: Investigator Site 33
state: Texas
city: San Antonio
country: United States
facility: Investigator Site 26
state: Texas
city: San Antonio
country: United States
facility: Investigator Site 29
state: Texas
city: San Antonio
country: United States
facility: Investigator Site 28
state: Texas
city: San Antonio
country: United States
facility: Investigator Site 25
state: Texas
city: Salt Lake City
country: United States
facility: Investigator Site 22
state: Utah
Study officials:
affiliation: Relypsa, Inc.
name: Study Director or VP Clinical Development
role: STUDY_DIRECTOR
References:
citation: 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.