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Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

Primary Purpose

Hyperkalemia, End Stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Patiromer Oral Powder Product
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperkalemia focused on measuring Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and Females, age at least 18 years
  • ESRD treated with thrice-weekly HD for ≥ 6 months.
  • At least two measured pre-dialysis serum [K] ≥ 5.5 mEq/L or one [K] ≥ 6.0 mEq/L noted over the past three months
  • Current use of dialysate with potassium concentration ≤ 2 mEq/L
  • Typical consumption of at least two meals per day
  • Have received customary dietary instruction over prior month
  • Considered by the treating physician(s) to be in otherwise stable clinical condition.
  • If patient is of childbearing potential, he/she will be willing to avoid pregnancy during the study using an acceptable birth control method.

Exclusion Criteria:

  • Not considered by the treating physician(s) to be adherent with recommended dialysis schedule and prescribed medications
  • Life expectancy < 3 months
  • Dialysis-dependent for less than 6 months
  • Non-elective hospitalization in prior 3 months
  • Currently prescription of oral potassium supplements
  • In the prior 3 months, therapy with oral potassium-lowering medication
  • Underlying severe gastrointestinal disorders, including history of ischemic bowel.
  • Corrected serum calcium concentration > 10.5 mg/dL in prior three months
  • Anticipated kidney transplant within the next 3 months
  • Prisoners or others who are involuntarily incarcerated or detained
  • Pregnant, breastfeeding, or considering pregnancy.
  • Participation in a clinical trial of an experimental treatment within the past 30 days

Sites / Locations

  • DaVita Dialysis Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patiromer Oral Powder Product

Usual care arm

Arm Description

Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L.

Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol

Outcomes

Primary Outcome Measures

Number of episodes of serum K ≥ 5.5 mEq/L
To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis

Secondary Outcome Measures

Percent of patients with serum K > 5.5 mEq/L
To determine the between-group differences in percent of patients with serum K > 5.5 mEq/L
Average dose of patiromer that was given in treatment arm
To determine the efficacy and dosing of patiromer in ESRD patients.
Number of additional hemodialysis treatments due to hyperkalemia.
To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia
Number of significant arrhythmia events as detected with cardiac monitors in Week 4.
To determine the between-group differences in pre-specified significant arrhythmia events as detected with cardiac monitors in Week 4.
Difference percentage in serum albumin concentrations.
To determine the between-group differences in serum albumin concentrations.
Difference percentage in PTH concentrations.
To determine the between-group differences in PTH concentrations.
Number of patients who completed all study visits.
To determine feasibility of a large-scale hemodialysis-based trial.
Change percentage in serum potassium concentration two weeks after study drug is discontinued.
To determine the change in serum potassium concentration two weeks after study drug is discontinued
Change percentage in serum phosphorus concentration two weeks after study drug has been discontinued.
To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued
Number of > 1000 PVC/24 hours.
Presence of > 1000 PVC/24 hours
Number of significant arrhythmias.
The between-group and Week-0-to-Week-4-differences in significant arrhythmias will be evaluated.

Full Information

First Posted
December 18, 2018
Last Updated
June 28, 2023
Sponsor
Duke University
Collaborators
Vifor Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03781089
Brief Title
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
Official Title
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated With Hemodialysis (PEARL-HD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Vifor Pharma

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 purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.
Detailed Description
This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from our clinical practice group. A total of 40 study participants (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks. This is a proof of concept study, to determine whether administration of patiromer has the potential to change the risk category for ESRD patients who are on conventional HD schedules. In addition, the study will develop and pilot study procedures that could be implemented in a large-scale clinical trial. By nature of the limited size of the study, the power of the trial will be limited. Reducing serum potassium with the use of low dialysate potassium is actually associated with an increased risk of sudden cardiac death. Furthermore, HD patients already carry a high pill burden, and it is unclear if prescription of an additional oral medication will reduce the frequency of episodic hyperkalemia.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from our clinical practice group. A total of 40 patients (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks.
Masking
Outcomes Assessor
Masking Description
The study is open-label and therefore the subjects, coordinators and investigators are not blinded to the intervention. Titration of the patiromer will require viewing of the serum potassium values. During the data analysis, however, personnel involved will remain blinded.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patiromer Oral Powder Product
Arm Type
Experimental
Arm Description
Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L.
Arm Title
Usual care arm
Arm Type
No Intervention
Arm Description
Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Intervention Type
Drug
Intervention Name(s)
Patiromer Oral Powder Product
Other Intervention Name(s)
Valtressa
Intervention Description
Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Primary Outcome Measure Information:
Title
Number of episodes of serum K ≥ 5.5 mEq/L
Description
To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent of patients with serum K > 5.5 mEq/L
Description
To determine the between-group differences in percent of patients with serum K > 5.5 mEq/L
Time Frame
4 weeks
Title
Average dose of patiromer that was given in treatment arm
Description
To determine the efficacy and dosing of patiromer in ESRD patients.
Time Frame
4 weeks
Title
Number of additional hemodialysis treatments due to hyperkalemia.
Description
To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia
Time Frame
4 weeks
Title
Number of significant arrhythmia events as detected with cardiac monitors in Week 4.
Description
To determine the between-group differences in pre-specified significant arrhythmia events as detected with cardiac monitors in Week 4.
Time Frame
4 weeks
Title
Difference percentage in serum albumin concentrations.
Description
To determine the between-group differences in serum albumin concentrations.
Time Frame
4 weeks
Title
Difference percentage in PTH concentrations.
Description
To determine the between-group differences in PTH concentrations.
Time Frame
4 weeks
Title
Number of patients who completed all study visits.
Description
To determine feasibility of a large-scale hemodialysis-based trial.
Time Frame
4 weeks
Title
Change percentage in serum potassium concentration two weeks after study drug is discontinued.
Description
To determine the change in serum potassium concentration two weeks after study drug is discontinued
Time Frame
6 weeks
Title
Change percentage in serum phosphorus concentration two weeks after study drug has been discontinued.
Description
To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued
Time Frame
6 weeks
Title
Number of > 1000 PVC/24 hours.
Description
Presence of > 1000 PVC/24 hours
Time Frame
4 weeks
Title
Number of significant arrhythmias.
Description
The between-group and Week-0-to-Week-4-differences in significant arrhythmias will be evaluated.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and Females, age at least 18 years ESRD treated with thrice-weekly HD for ≥ 6 months. At least two measured pre-dialysis serum [K] ≥ 5.5 mEq/L or one [K] ≥ 6.0 mEq/L noted over the past three months Current use of dialysate with potassium concentration ≤ 2 mEq/L Typical consumption of at least two meals per day Have received customary dietary instruction over prior month Considered by the treating physician(s) to be in otherwise stable clinical condition. If patient is of childbearing potential, he/she will be willing to avoid pregnancy during the study using an acceptable birth control method. Exclusion Criteria: Not considered by the treating physician(s) to be adherent with recommended dialysis schedule and prescribed medications Life expectancy < 3 months Dialysis-dependent for less than 6 months Non-elective hospitalization in prior 3 months Currently prescription of oral potassium supplements In the prior 3 months, therapy with oral potassium-lowering medication Underlying severe gastrointestinal disorders, including history of ischemic bowel. Corrected serum calcium concentration > 10.5 mg/dL in prior three months Anticipated kidney transplant within the next 3 months Prisoners or others who are involuntarily incarcerated or detained Pregnant, breastfeeding, or considering pregnancy. Participation in a clinical trial of an experimental treatment within the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Middleton, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Dialysis Sites
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant level data will not be shared.
Citations:
PubMed Identifier
32588430
Citation
Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
Results Reference
derived

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Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

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