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

Completed · Phase 2

Conditions studied: ESRD, Hyperkalemia, End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT03326583

Run by

Dominic Raj

People needed

27

Starts

2017-11-01

Expected to finish

2020-12-31

Last updated by the study team

2023-05-09

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• DaVita K Street — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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