NCT03326583

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Dominic Raj · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.

Conditions

• ESRD
• Hyperkalemia
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Patiromer	Patiromer will be orally self-administered by participants.

Timeline

• Start date: 2017-11-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-10-31
• Last updated: 2023-05-09
• Results posted: 2023-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study