Patiromer With or Without Food for the Treatment of Hyperkalemia
- Registration Number
- NCT02694744
- Lead Sponsor
- Relypsa, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 - Dosing Without Food patiromer Patiromer dosing without food Group 2 - Dosing With Food patiromer Patiromer dosing with food
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mean Change in Serum Potassium From Baseline to Week 4 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.
Trial Locations
- Locations (29)
Investigator Site 12
🇺🇸Fountain Valley, California, United States
Investigator Site 20
🇺🇸Riverside, California, United States
Investigator Site 10
🇺🇸Hialeah, Florida, United States
Investigator Site 13
🇺🇸Hollywood, Florida, United States
Investigator Site 15
🇺🇸Miami, Florida, United States
Investigator Site 23
🇺🇸Flint, Michigan, United States
Investigator Site 36
🇺🇸Norman, Oklahoma, United States
Investigator Site 11
🇺🇸Huntington Beach, California, United States
Investigator Site 44
🇺🇸Meridian, Idaho, United States
Investigator Site 43
🇺🇸Miami, Florida, United States
Investigator Site 37
🇺🇸Flushing, New York, United States
Investigator Site 28
🇺🇸San Antonio, Texas, United States
Investigator Site 26
🇺🇸San Antonio, Texas, United States
Investigator Site 29
🇺🇸San Antonio, Texas, United States
Investigator Site 25
🇺🇸San Antonio, Texas, United States
Investigator Site 22
🇺🇸Salt Lake City, Utah, United States
Investigator Site 38
🇺🇸Palm Springs, California, United States
Investigator Site 21
🇺🇸San Dimas, California, United States
Investigator Site 30
🇺🇸Edgewater, Florida, United States
Investigator Site 17
🇺🇸Lauderdale Lakes, Florida, United States
Investigator Site 41
🇺🇸Las Vegas, Nevada, United States
Investigator Site 40
🇺🇸Jackson, Tennessee, United States
Investigator Site 33
🇺🇸Dallas, Texas, United States
Investigator Site 16
🇺🇸Lauderdale Lakes, Florida, United States
Investigator Site 18
🇺🇸Pembroke Pines, Florida, United States
Investigator Site 39
🇺🇸Aurora, Illinois, United States
Investigator Site 24
🇺🇸Denver, Colorado, United States
Investigator Site 27
🇺🇸Tampa, Florida, United States
Investigator Site 34
🇺🇸Kansas City, Missouri, United States