Clinical trial NCT03326583: The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Official title: The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ESRD
Hyperkalemia
End Stage Renal Disease
Keywords: End Stage Renal Disease
ESRD
Hyperkalemia
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
measure: Serum Potassium Level Through 12 Weeks of Treatment
timeFrame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
measure: Changes in Blood Chemistry During the Study
timeFrame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
measure: Stool Electrolytes During the Study Phases
timeFrame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Secondary outcomes:
measure: Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer
timeFrame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
measure: Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.
timeFrame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)
Other outcomes:
Locations:
city: Washington
country: United States
facility: DaVita K Street
state: District of Columbia
Study officials:
References:
citation: Amdur RL, Paul R, Barrows ED, Kincaid D, Muralidharan J, Nobakht E, Centron-Vinales P, Siddiqi M, Patel SS, Raj DS. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020 Nov;98(5):1331-1340. doi: 10.1016/j.kint.2020.06.042. Epub 2020 Aug 1.