Status:
COMPLETED
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Lead Sponsor:
Dominic Raj
Conditions:
ESRD
Hyperkalemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03326583
Start Date
November 1 2017
End Date
December 31 2020
Last Update
May 9 2023
Active Locations (1)
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1
DaVita K Street
Washington D.C., District of Columbia, United States, 20037