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Trial details
Trial details
Single dose study to evaluate how intravenous administered difelikefalin is absorbed by and cleared from Adolescents on Haemodialysis
Current status:
Approved
|
Date registered:
07/02/2023
|
Date last updated:
16/12/2022
Trial version(s)
History: 21/11/2022
Current: 21/11/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022125201
Protocol number
KOR-PED-201
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Prevalence of the disease is low in Switzerland and potential sites might not be able to enroll patients during the planned duration of the study
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Vifor Fresenius Medical Care Renal Pharma Ltd.
Primary sponsor: Country of origin
Switzerland
Public title
Single dose study to evaluate how intravenous administered difelikefalin is absorbed by and cleared from Adolescents on Haemodialysis
Acronym
Scientific title
An Open-label, Single Arm Study to Evaluate the Pharmacokinetics of a Single Dose of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis
Acronym
Brief summary of the study: English
This is an open-label study to evaluate the activity of a single dose of intravenous Difelikefalin in the body, including its absorption, distribution and excretion from the body, in adolescents aged 12 to 17 Years on haemodialysis.
Brief summary of the study: Arabic
هذه دراسة مفتوحة التسمية لتقييم نشاط جرعة واحدة من Difelikefalin عن طريق الوريد في الجسم ، بما في ذلك امتصاصه، توزيعه وإفرازه من الجسم ، لدى المراهقين الذين تتراوح أعمارهم بين 12 و 17 عامًا يخضعون لغسيل الكلى.
Health conditions/problem studied: Specify
Patients with chronic kidney disease undergoing hemodialysis
Interventions: Specify
Drug: Difelikefalin (CR845)
Key inclusion and exclusion criteria: Inclusion criteria
1. End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months and are currently on HD at least 3 times per week. Subjects with or without associated pruritus may enroll. 2. Males or females 12 to 17 years of age, at the time of consent. 3. Has a prescription dry body weight ≥20 kg and ≤100 kg.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
17
Key inclusion and exclusion criteria: Exclusion criteria
1. Known to be non-compliant with HD treatments and deemed unlikely to complete the study by the Investigator (i.e., has a history of missed HD sessions due to non-adherence in the past 2 months). 2. Planned or anticipated to receive a kidney transplant during the study. Note: Being on a kidney transplant list is not an exclusion criterion. 3. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin greater than 4 × the ULN at screening. 4. Subject has known hypersensitivity to the study drug or any components of the difelikefalin formulation. 5. Known history of allergic reaction to opiates such as hives. Note: Side effects related to the use of opioids such as constipation or nausea would not exclude the subjects from the study. 6. Previous participation in this study. 7. Known or suspected history of alcohol, narcotic, or other drug abuse or substance dependence within 12 months prior to screening. 8. Acute or unstable medical condition(s) which in the opinion of the Investigator would pose undue risk to the subject or would impede complete collection of evaluable data.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Pharmacokinetics, tolerability and safety
Study design: Allocation
Single Arm Study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
2
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
USA, Germany, Austria, Netherlands
Name of IMP
KORSUVA (US), KAPRUVIA (EU)
Year of authorization
2021
Month of authorization
8
Type of IMP
Others
Type of IMP: Specify
Pharmaceutical
Pharmaceutical class
Selective Kappa-Opioid Receptor (KOR) full agonist
Therapeutic indication
moderate-to-severe pruritus associated with chronic kidney disease in patients on haemodialysis
Therapeutic benefit
Opioid receptors are involved in the modulation of pruritus and pain signals and consist mainly of 3 subtypes, classified as mu, kappa, and delta. These receptor subtypes are found in the CNS (ie, brain and spinal cord), on sensory ganglionic neurons and their nerve fibers innervating peripheral tissues such as skin, and on certain cell types of the immune system. Most clinically used opioid analgesics act primarily via activation of mu-opioid receptors located in the CNS and peripheral nervous system. As such, there are associated with a wide array of side effects, such as sedation, respiratory depression, abuse liability, cardiovascular collapse, and death. To avoid these undesirable effects, difelikefalin was designed to only activate KORs, which are known to modulate visceral and inflammatory pain, pruritus, and inflammatory signals in animals and humans.
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
3
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
02/01/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
30/06/2023
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
-
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
EU Clinical Trials Register
EudraCT Number: 2021-000894-94
Sources of Monetary or Material Support
Name
Vifor Fresenius Medical Care Renal Pharma Ltd.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Diana
Salameh
Beirut
Lebanon
+961 3 902 515
diana.salame@worldwide.com
Worldwide Clinical Trials
Scientific
Milica
Enoiu
Flughofstrasse 61, CH-8152 Glattbrugg
Switzerland
-
milica.enoiu@viforpharma.com
Vifor Fresenius Medical Care Renal Pharma Ltd.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France hospital
Dr. Chebl Mourani
Pediatric Nephrology
Approved
Saint Georges University Medical Center
Dr. Pauline Abou Jaoude
Pediatric Nephrology
Pending
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
02/11/2022
Pr. Sami Richa
-
+9611604000
Countries of Recruitment
Name
Lebanon
Italy
United Kingdom
Health Conditions or Problems Studied
Condition
Code
Keyword
Chronic kidney disease associated pruritus in haemodialysis patients
Pruritus (L29)
pruritus, kidney disease, pediatric
Chronic kidney disease associated pruritus in hemodialysis patients
Chronic renal failure (N18)
CKD, associated pruritus
Interventions
Intervention
Description
Keyword
Drug
Difelikefalin (CR845)
KOR agonist
Primary Outcomes
Name
Time points
Measure
PK profile of difelikefalin after a single dose post-HD
Day 1, 2 and 3
PK sampling
Key Secondary Outcomes
Name
Time points
Measure
Incidence of adverse events (AEs) and serious adverse events (SAEs)
From Day 1 to Day 7
Documentation of all AEs occurred during conduct of study
Incidence of adverse events (AEs) and serious adverse events (SAEs)
From Day 1 to Day 7
Measurement of vital signs, ECG measurements, blood tests
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial