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

Primary Purpose

ESRD, Hyperkalemia, End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Patiromer
Sponsored by
Dominic Raj
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ESRD focused on measuring End Stage Renal Disease, ESRD, Hyperkalemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • DaVita K Street

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patiromer

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Serum Potassium Level Through 12 Weeks of Treatment
Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20
Changes in Blood Chemistry During the Study
Stool Electrolytes During the Study Phases

Secondary Outcome Measures

Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer
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.
Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.
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.

Full Information

First Posted
October 6, 2017
Last Updated
April 19, 2023
Sponsor
Dominic Raj
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1. Study Identification

Unique Protocol Identification Number
NCT03326583
Brief Title
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Official Title
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dominic Raj

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESRD, Hyperkalemia, End Stage Renal Disease
Keywords
End Stage Renal Disease, ESRD, Hyperkalemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patiromer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Patiromer
Intervention Description
Patiromer will be orally self-administered by participants.
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Title
Serum Potassium Level Through 12 Weeks of Treatment
Description
Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20
Time Frame
Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Title
Changes in Blood Chemistry During the Study
Time Frame
Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Title
Stool Electrolytes During the Study Phases
Time Frame
Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Secondary Outcome Measure Information:
Title
Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer
Description
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.
Time Frame
Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Title
Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.
Description
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.
Time Frame
Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
DaVita K Street
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32750456
Citation
Amdur RL, Paul R, Barrows ED, Kincaid D, Muralidharan J, Nobakht E, Centron-Vinales P, Siddiqi M, Patel SS, Raj DS. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020 Nov;98(5):1331-1340. doi: 10.1016/j.kint.2020.06.042. Epub 2020 Aug 1.
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The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia

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