Single dose study to evaluate how intravenous administered difelikefalin is absorbed by and cleared from Adolescents on Haemodialysis

Phase 1

• Conditions: Renal disease in the final stage; MedDRA version: 21.1Level: LLTClassification code 10014646Term: End stage renal disease (ESRD)System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 21.0Level: PTClassification code 10077512Term: End stage renal diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-000894-94-IT
• Lead Sponsor: Vifor Fresenius Medical Care Renal Pharma Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-30
• Study Completion: 2023-05-30
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified