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

• Status: Active, not recruiting
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dominic Raj

Criteria

Inclusion Criteria:

• Subjects on stable hemodialysis for more than 90 days.

• Age 18-85 years.

• Persistent hyperkalemia, defined as elevated serum potassium > 5.0 mEq/L in more than 2 occasions during the previous 3 months.

Exclusion Criteria:

• Use of pre- or probiotics during the past 2 months

• Use of antibiotics within the past 2 months, if the patient received a single course of antibiotic.

• Presence of chronic wound infection and osteomyelitis

• Inflammatory bowel disease, chronic diarrhea, current C. difficile infection

• Liver cirrhosis or chronic active hepatitis

• Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone > 10 mg in the last 3 months

• Anticipated kidney transplant within 9 months

• Expected survival < 9 months

• Pregnancy, anticipated pregnancy, or breastfeeding

• Incarceration

• Participation in another intervention study

• severe anemia defined as hemoglobin < 8.0 g/dl any time during the last 2 months