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

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ClinicalTrials.gov Identifier: NCT03326583
Recruitment Status : Completed
First Posted : October 31, 2017
Results First Posted : March 22, 2023
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
Dominic Raj, George Washington University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Sequential 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 : November 1, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Patiromer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Drug: Patiromer
Patiromer will be orally self-administered by participants.


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) ]

    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


  2. Serum Potassium Level Through 12 Weeks of Treatment [ Time Frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) ]
    Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20

  3. Changes in Blood Chemistry During the Study [ Time Frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) ]
  4. Stool Electrolytes During the Study Phases [ Time Frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) ]

Secondary Outcome Measures :
  1. Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer [ Time Frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) ]
    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
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326583


Locations
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United States, District of Columbia
DaVita K Street
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
Dominic Raj
  Study Documents (Full-Text)

Documents provided by Dominic Raj, George Washington University:
Study Protocol and Statistical Analysis Plan  [PDF] July 25, 2017

More Information
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Additional Information:

Publications of Results:

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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: October 31, 2017    Key Record Dates
Results First Posted: March 22, 2023
Last Update Posted: March 22, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dominic Raj, George Washington University:
End Stage Renal Disease
ESRD
Hyperkalemia
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Hyperkalemia
Urologic Diseases
 Renal Insufficiency, Chronic
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases