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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 : Recruiting
First Posted : October 31, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dominic Raj, George Washington University

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 Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Patiromer

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.



Primary Outcome Measures :
  1. 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 [ Time Frame: 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.

  2. Stopping Patiromer medication of participants [ Time Frame: 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.

  3. Adverse events of participants taking Patiromer in lowering serum potassium levels in ESRD patients with hyperkalemia [ Time Frame: 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 :
  1. Changes in gut microbiome of hyperkalemic ESRD patients treated with Patiromer. [ Time Frame: 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.

  2. Changes in plasma metabolites using p-Cresol of hyperkalemic ESRD patients treated with Patiromer [ Time Frame: 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.



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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

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


Contacts
Contact: Christina Franco, MPH 202-741-2284 cfranco@mfa.gwu.edu
Contact: Sarah Andrews, BS 202-741-2571 scandrews@mfa.gwu.edu

Locations
United States, District of Columbia
DaVita K Street Recruiting
Washington, District of Columbia, United States, 20037
Contact: Christina Franco, MPH    202-741-2284    cfranco@mfa.gwu.edu   
Principal Investigator: Dominic Raj, MD         
Sponsors and Collaborators
Dominic Raj

Responsible Party: Dominic Raj, Director of the Division of Renal Disease and Hypertension, Professor of Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT03326583     History of Changes
Other Study ID Numbers: 071738
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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:
Kidney Diseases
Kidney Failure, Chronic
Hyperkalemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases