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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03781089
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2018
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
Relypsa, Inc.
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Hyperkalemia End Stage Renal Disease Drug: Patiromer Oral Powder Product Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Prevention
Official Title: Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated With Hemodialysis (PEARL-HD)
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : June 20, 2021
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Patiromer

Arm Intervention/treatment
Experimental: Patiromer Oral Powder Product
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.
Drug: Patiromer Oral Powder Product
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
Other Name: Valtressa

No Intervention: Usual care arm
Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol



Primary Outcome Measures :
  1. Number of episodes of serum K ≥ 5.5 mEq/L [ Time Frame: 4 weeks ]
    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 :
  1. Percent of patients with serum K > 5.5 mEq/L [ Time Frame: 4 weeks ]
    To determine the between-group differences in percent of patients with serum K > 5.5 mEq/L

  2. Average dose of patiromer that was given in treatment arm [ Time Frame: 4 weeks ]
    To determine the efficacy and dosing of patiromer in ESRD patients.

  3. Number of additional hemodialysis treatments due to hyperkalemia. [ Time Frame: 4 weeks ]
    To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia

  4. Number of significant arrhythmia events as detected with cardiac monitors in Week 4. [ Time Frame: 4 weeks ]
    To determine the between-group differences in pre-specified significant arrhythmia events as detected with cardiac monitors in Week 4.

  5. Difference percentage in serum albumin concentrations. [ Time Frame: 4 weeks ]
    To determine the between-group differences in serum albumin concentrations.

  6. Difference percentage in PTH concentrations. [ Time Frame: 4 weeks ]
    To determine the between-group differences in PTH concentrations.

  7. Number of patients who completed all study visits. [ Time Frame: 4 weeks ]
    To determine feasibility of a large-scale hemodialysis-based trial.

  8. Change percentage in serum potassium concentration two weeks after study drug is discontinued. [ Time Frame: 6 weeks ]
    To determine the change in serum potassium concentration two weeks after study drug is discontinued

  9. Change percentage in serum phosphorus concentration two weeks after study drug has been discontinued. [ Time Frame: 6 weeks ]
    To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued

  10. Number of > 1000 PVC/24 hours. [ Time Frame: 4 weeks ]
    Presence of > 1000 PVC/24 hours

  11. Number of significant arrhythmias. [ Time Frame: 4 weeks ]
    The between-group and Week-0-to-Week-4-differences in significant arrhythmias will be evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03781089


Locations
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United States, North Carolina
DaVita Dialysis Sites
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Duke University
Relypsa, Inc.
Investigators
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Principal Investigator: John P Middleton, MD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03781089    
Other Study ID Numbers: Pro00088688
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant level data will not be shared.

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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 Duke University:
Hemodialysis
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