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

Sponsor

Dominic Raj (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03326583

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ESRD Hyperkalemia End Stage Renal Disease	Drug: Patiromer	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No Intervention: Pre-Treatment This arm is the 2 week observation period before the start of the Patiromer treatment phase.
Experimental: Intervention: Treatment This arm is the 12 week treatment phase. 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.	Drug: Patiromer Patiromer will be orally self-administered by participants.
No Intervention: No Intervention: Post-Treatment This arm is the 2 week observation period after the Patiromer treatment phase.

Arm

Intervention/Treatment

No Intervention: No Intervention: Pre-Treatment

This arm is the 2 week observation period before the start of the Patiromer treatment phase.

Experimental: Intervention: Treatment

This arm is the 12 week treatment phase. 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.

Drug: Patiromer

Patiromer will be orally self-administered by participants.

No Intervention: No Intervention: Post-Treatment

This arm is the 2 week observation period after the Patiromer treatment phase.

Outcome Measures

Primary Outcome Measures

Change in the Gastrointestinal Symptom Rating Scale (GSRS) measuring symptoms from none at all, mild, moderate, and severe through patient interview of participants taking Patiromer in lowering serum potassium levels in ESRD patients with hyperkalemia [20 weeks]
Patients with hyperkalemia will be in a 3 sequential phase pilot clinical trial of no intervention, Patiromer treatment at 8.4-16.8 g/day, and no intervention. Blood and stool samples will be collected throughout the study. These measures will be used to examine the tolerability, safety, and efficacy of the study drug.
Stopping Patiromer medication of participants [12 weeks]
Patients with hyperkalemia will be in a 3 sequential phase pilot clinical trial of no intervention, Patiromer treatment at 8.4-16.8 g/day, and no intervention. Blood and stool samples will be collected throughout the study. These measures will be used to examine the tolerability, safety, and efficacy of the study drug.
Adverse events of participants taking Patiromer in lowering serum potassium levels in ESRD patients with hyperkalemia [20 weeks]
Patients with hyperkalemia will be in a 3 sequential phase pilot clinical trial of no intervention, Patiromer treatment at 8.4-16.8 g/day, and no intervention. Blood and stool samples will be collected throughout the study. These measures will be used to examine the tolerability, safety, and efficacy of the study drug.

Secondary Outcome Measures

Changes in gut microbiome of hyperkalemic ESRD patients treated with Patiromer. [20 weeks]
Blood and stool samples collected from the ESRD patient will be collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile.
Changes in plasma metabolites using p-Cresol of hyperkalemic ESRD patients treated with Patiromer [20 weeks]
Blood and stool samples collected from the ESRD patient will be collected at pre-specified time points and analyzed by untargeted and targeted metabolomics for stool and serum metabolome profiles.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DaVita K Street	Washington	District of Columbia	United States	20037

Sponsors and Collaborators

Dominic Raj

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dominic Raj, Director of the Division of Renal Disease and Hypertension, Professor of Medicine, George Washington University

ClinicalTrials.gov Identifier:

NCT03326583

Other Study ID Numbers:

071738

First Posted:

Oct 31, 2017

Last Update Posted:

Dec 19, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Dominic Raj, Director of the Division of Renal Disease and Hypertension, Professor of Medicine, George Washington University

End Stage Renal Disease

ESRD

Hyperkalemia

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Hyperkalemia

Study Results

No Results Posted as of Dec 19, 2018