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

NCT03781089 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00088688
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia; End Stage Renal Disease

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Total Number of Episodes of Serum Potassium ≥ 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.

  Week 4

Secondary Outcomes (11)

• Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant

  4 weeks

• Median Daily Dose of Patiromer That Was Given in Treatment Arm

  Week 3

• Number of Additional Hemodialysis Treatments Due to Hyperkalemia

  4 weeks

• Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline

  Baseline

• Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4

  Week 4

Study Arms (2)

Patiromer Oral Powder Product

EXPERIMENTAL

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

Usual care arm

NO INTERVENTION

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

Interventions

Patiromer Oral Powder Product DRUG

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

Also known as: Valtressa

Patiromer Oral Powder Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Vifor Pharma: collaborator

Study Sites (1)

DaVita Dialysis Sites

Durham, North Carolina, 27713, United States

Location

Related Publications (1)

• 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.

  PMID: 32588430 DERIVED

MeSH Terms

Conditions

Hyperkalemia; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. John Middleton
• Organization: Duke University Medical Center

j.p.middleton@duke.edu

919-684-8111

Study Officials

• John P Middleton, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: June 20, 2019
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)