The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 12/21/2018 |
| Start Date: | November 1, 2017 |
| End Date: | April 2020 |
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia
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.
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.
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
We found this trial at
1
site
2131 K Street Northwest
Washington, District of Columbia 20037
Washington, District of Columbia 20037
Principal Investigator: Dominic Raj, MD
Phone: 202-741-2284
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