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

Dominic Raj27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ESRD Hyperkalemia End Stage Renal Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

The Gastrointestinal Symptom Rating Scale was used to measures any potential side effects due to study medication. Survey was administered at Wk 1, Wk 8, Wk 14, and Wk 20. For symptoms (abdomen pain - diarrhea) a score of 0 indicates "no discomfort", 1 = "mild discomfort", 2=moderate, 3=severe; higher score means a worse outcome For stool form, 1=Well formed, 2=Semi formed, 3= Loose, 4= Liquid;higher score means a worse outcome For number of stools per day, 1= \<1, 2=1 or 2, 3=3 or 4, 4=5 or 6,5= 7 or more; higher score means a worse outcome