Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593392
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis with Moderate-to-Severe Pruritus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
KOR-PED-202 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale
People with long term kidney disease who are on haemodialysis a procedure for removing waste products from the blood commonly develop a condition that makes their skin very itchy
Difelikefalin is a medicine that can treat the itching related to long term kidney disease
Clinical studies have shown difelikefalin to reduce itching in adults on haemodialysis while being safe and tolerable
The current study is being done in adolescents aged 12 to 17 years on haemodialysis who have moderate to severe itching related to long term kidney disease to assess if difelikefalin is safe in this age group
The aims of the study are
Main aim To assess the safety of difelikefalin in adolescents who are on haemodialysis and have itching related to long term kidney disease
Secondary aim To measure the amount of difelikefalin that enters the blood in adolescents who are on haemodialysis and have itching related to long term kidney disease
Study Design At least 18 adolescents aged 12 to 17 years who are on haemodialysis and have itching related to long term kidney disease will take part in this study
All study participants will receive difelikefalin 3 or up to 4 times weekly for up to 12 weeks The study duration for a participant is up to 17 to 18 weeks during this period participants will visit the clinic 3 times weekly during their haemodialysis visits
People with long term kidney disease who are on haemodialysis a procedure for removing waste products from the blood commonly develop a condition that makes their skin very itchy
Difelikefalin is a medicine that can treat the itching related to long term kidney disease
Clinical studies have shown difelikefalin to reduce itching in adults on haemodialysis while being safe and tolerable
The current study is being done in adolescents aged 12 to 17 years on haemodialysis who have moderate to severe itching related to long term kidney disease to assess if difelikefalin is safe in this age group
The aims of the study are
Main aim To assess the safety of difelikefalin in adolescents who are on haemodialysis and have itching related to long term kidney disease
Secondary aim To measure the amount of difelikefalin that enters the blood in adolescents who are on haemodialysis and have itching related to long term kidney disease
Study Design At least 18 adolescents aged 12 to 17 years who are on haemodialysis and have itching related to long term kidney disease will take part in this study
All study participants will receive difelikefalin 3 or up to 4 times weekly for up to 12 weeks The study duration for a participant is up to 17 to 18 weeks during this period participants will visit the clinic 3 times weekly during their haemodialysis visits
Detailed Description:
The purpose of this study is to evaluate the safety and tolerability as assessed by incidence of AEs of 05 μgkg IV difelikefalin in adolescent participants on HD 3 times weekly with moderate-to-severe pruritus over 12 weeks Additionally difelikefalin plasma concentrations Cmax and Ctrough after multiple administrations will be evaluated at a few selected time points and the efficacy of difelikefalin in improving itching and health-related QoL will be investigated as exploratory
Study details include
The study duration for a single participant will be up to 17 to 18 weeks
The treatment duration for each participant will be up to 12 weeks
The visit frequency will be 3 times weekly during HD visits
Trial Population
Participants in this study must
Be male or female adolescent participants 12 to 18 years of age at the time of informed consentassent
Have CKD-aP on HD at least 3 hours in duration 3 times weekly for at least 12 weeks prior to the informed consent procedure
Be able to continue HD without changing its frequency or method
Have a mean value WI-NRS score during the run-in period of 40 moderate-to-severe pruritus
Participants in this study must not
Be planned to receive a kidney transplant during the study
Have known severe hepatic impairment eg Child-Pugh Class C or concurrent hepatic cirrhosis serum alanine aminotransferase ALT or aspartate aminotransferase AST 3 times the reference upper limit of normal ULN significant systolic or diastolic heart failure or concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin or carcinoma in situ that has been excised or resected completely
Number of Participants
At least 18 participants evaluable for the primary safety endpoint will be enrolled in the study Note Enrolled means participants or their legally acceptable representatives agreement to participate in a clinical study following completion of the informed consent process and screening A participant will only be considered enrolled if the informed consentassent is not withdrawn prior to participating in any study activity after screening including the run-in period
Study Arms and Duration
This is a single-arm open-label study All participants will receive IV difelikefalin at a dose of 05 μgkg of dry body weight after each HD treatment 3 times weekly for 12 weeks
The study includes a screening period of up to 4 weeks including a 7-day run-in period during the week prior to enrolment a study treatment period of 12 weeks and a follow-up period of 7 up to 10 days
If for any reason difelikefalin is interrupted for more than 1 week the participant should be withdrawn from the study intervention
Study details include
The study duration for a single participant will be up to 17 to 18 weeks
The treatment duration for each participant will be up to 12 weeks
The visit frequency will be 3 times weekly during HD visits
Trial Population
Participants in this study must
Be male or female adolescent participants 12 to 18 years of age at the time of informed consentassent
Have CKD-aP on HD at least 3 hours in duration 3 times weekly for at least 12 weeks prior to the informed consent procedure
Be able to continue HD without changing its frequency or method
Have a mean value WI-NRS score during the run-in period of 40 moderate-to-severe pruritus
Participants in this study must not
Be planned to receive a kidney transplant during the study
Have known severe hepatic impairment eg Child-Pugh Class C or concurrent hepatic cirrhosis serum alanine aminotransferase ALT or aspartate aminotransferase AST 3 times the reference upper limit of normal ULN significant systolic or diastolic heart failure or concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin or carcinoma in situ that has been excised or resected completely
Number of Participants
At least 18 participants evaluable for the primary safety endpoint will be enrolled in the study Note Enrolled means participants or their legally acceptable representatives agreement to participate in a clinical study following completion of the informed consent process and screening A participant will only be considered enrolled if the informed consentassent is not withdrawn prior to participating in any study activity after screening including the run-in period
Study Arms and Duration
This is a single-arm open-label study All participants will receive IV difelikefalin at a dose of 05 μgkg of dry body weight after each HD treatment 3 times weekly for 12 weeks
The study includes a screening period of up to 4 weeks including a 7-day run-in period during the week prior to enrolment a study treatment period of 12 weeks and a follow-up period of 7 up to 10 days
If for any reason difelikefalin is interrupted for more than 1 week the participant should be withdrawn from the study intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None