Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial (PRINCE)

NCT06858280 Phase 3 RECRUITING

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.

Details

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	Phase 3
Status	RECRUITING
Enrolment	40
Start date	2025-07-08
Completion	2026-07

Conditions

• Hyperkalaemia
• Chronic Kidney Disease Stage 3 and 4
• Dietary Intervention

Interventions

• Patiromer 8400 MG [Veltassa]
• Placebo

Primary outcomes

• Serum potassium levels — Before every dialysis session for 12 weeks after recruitment
  Change in serum potassium levels of 0.5mEq/L compared to baseline

Countries

Italy