| Trial ID: | L0163 |
| Source ID: | NCT06593392
|
| Associated Drug: |
Difelikefalin
|
| Title: |
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Pruritus|Chronic Kidney Diseases
|
| Interventions: |
DRUG: Difelikefalin
|
| Outcome Measures: |
Primary: Incidence of adverse events (AEs), To evaluate the safety of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus, Up to 18 weeks | Secondary: Pre-dose difelikefalin plasma concentrations (Cpre), To evaluate difelikefalin plasma concentrations after multiple administrations of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus, 12 weeks|Trough difelikefalin plasma concentrations (Ctrough), To evaluate difelikefalin plasma concentrations after multiple administrations of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus, 12 Weeks|Maximum difelikefalin plasma concentrations (Cmax), To evaluate difelikefalin plasma concentrations after multiple administrations of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus, 12 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Vifor Fresenius Medical Care Renal Pharma
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-12-29
|
| Completion Date: |
2029-08-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-14
|
| Locations: |
Royal Hospital for Children Glasgow - 82600073, Glasgow, G51 4TF, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT06593392
|
