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

Dominic Raj

Status and phase: Completed; Phase 2

Conditions: Hyperkalemia; ESRD; End Stage Renal Disease

Treatments: Drug: Patiromer

Study type: Interventional

Funder types: Other

Identifiers

NCT03326583

071738

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Patiromer

Experimental group

Description:

This arm is a 2 week observation period before the start of the Patiromer treatment phase, followed by a 12 week treatment phase, and 6 week no treatment observation phase. Pre-Treatment (Wk 1-2): Observational period. Baseline sample collection of blood and stool. No medication. Treatment (Wk 3-14): Participants will take 8.4 grams of Patiromer once daily for one week, during which serum potassium and gastrointestinal symptoms will be evaluated. If tolerated and in the absence of hypokalemia, the dose will be up-titrated to 16.8 grams once daily for the remaining 11 weeks. Blood and stool will be collected. Post-Treatment (Wk 15-20): Observational period. No medication. Blood and stool will be collected.

Treatment:

Drug: Patiromer