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Patiromer and Diet/hrQoL in Chronic Dialysis

Study acronym: PRINCE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 4, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Jul 8, 2025
    • Site details revised
    v4
  2. Primary and study completion dates: Feb 2026 to Jul 2026
    • Start date: Jun 15, 2025 to Jul 2025
    • Eligibility criteria shortened, about 10 words
    • Study description expanded, about 208 words
    v3
  3. Site contact updatedv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.
Trial Details
NCT Number NCT06858280
Lead Sponsor Mario Negri Institute for Pharmacological Research
Conditions
(from sponsor)		 Hyperkalaemia, Chronic Kidney Disease Stage 3 and 4, Dietary Intervention
Related terms Hyperkalemia, Renal Insufficiency, Chronic
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov