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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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ESRD Hyperkalemia End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patiromer

This arm is a 2 week observation period before the start of the Patiromer treatment phase, followed by a 12 week treatment phase, and 6 week no treatment observation phase.

Pre-Treatment (Wk 1-2): Observational period. Baseline sample collection of blood and stool. No medication.

Treatment (Wk 3-14): Participants will take 8.4 grams of Patiromer once daily for one week, during which serum potassium and gastrointestinal symptoms will be evaluated. If tolerated and in the absence of hypokalemia, the dose will be up-titrated to 16.8 grams once daily for the remaining 11 weeks. Blood and stool will be collected.

Post-Treatment (Wk 15-20): Observational period. No medication. Blood and stool will be collected.

Group Type EXPERIMENTAL

Patiromer

Intervention Type DRUG

Patiromer will be orally self-administered by participants.

Interventions

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Patiromer

Patiromer will be orally self-administered by participants.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No