Phase 4 N=114 Randomized Treatment

Patiromer With or Without Food for the Treatment of Hyperkalemia

Hyperkalemia

Bottom Line

View on ClinicalTrials.gov: NCT02694744 ↗

Enrolled (actual)

114

Serious AEs

4.4%

Results posted

Nov 2017

Primary outcome: Primary: Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 — 82.5; 87.3 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: patiromer (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Relypsa, Inc.
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4	82.5; 87.3	—
SECONDARY Mean Change in Serum Potassium From Baseline to Week 4	-0.62; -0.65	0.7893

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02694744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.