Patiromer With or Without Food for the Treatment of Hyperkalemia
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/22/2017 |
Start Date: | February 2016 |
End Date: | August 2016 |
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)
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).
once daily (QD) when given with food compared to without food (experimental treatment group)
for the treatment of hyperkalemia (high potassium in the blood).
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.
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.
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
We found this trial at
30
sites
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