An Open-label, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis with Moderate-to-Severe Pruritus (KOR-PED-202)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509909-74-00

Acronym

KOR-PED-202

Enrollment

Registered

2025-03-31

Start date

2025-08-13

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Pruritus

Brief summary

Incidence of AEs.

Detailed description

Pre-dose difelikefalin plasma concentrations (Cpre), Trough difelikefalin plasma concentrations (Ctrough), Maximum difelikefalin plasma concentrations (Cmax)

Interventions

DRUGKapruvia 50 micrograms/mL solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Incidence of AEs.	—

Secondary

Measure	Time frame
Pre-dose difelikefalin plasma concentrations (Cpre), Trough difelikefalin plasma concentrations (Ctrough), Maximum difelikefalin plasma concentrations (Cmax)	—

Countries

Greece, Italy, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026