Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

CSL Vifor

Status and phase

Completed

Phase 1

Conditions

End Stage Renal Disease on Hemodialysis

Treatments

Drug: Difelikefalin Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05885763

JXHL2101166 (Other Identifier)

KOR-CHINA-101

Details and patient eligibility

About

This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.

Full description

Total study duration for a single subject is up to 5 weeks including a screening period of up to 3 weeks, a treatment period of 1 week, and a safety follow-up period of 1 week.

The duration of PK sampling is 12 days.

The primary objective of the study is to evaluate the PK profile of a repeated (3 times weekly) dose of difelikefalin in Chinese HD subjects over a 1-week treatment period.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months before enrolment in the study and are currently on HD 3 times per week.
Subjects with a prescription dry body weight between 40 and 100 kg, inclusive.
If female, is not pregnant, or nursing
If female:
1. Is surgically sterile; or
2. Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or
3. Has a negative serum pregnancy test within 7 days before first dose of investigational product, and agrees to use adequate contraceptive precautions (e.g., hormonal contraceptives, barrier with spermicide, intrauterine device, vasectomised partner, or abstinence) from the time of informed consent until 7 days after the last dose of investigational product.
If male, agrees not to donate sperm from the first dose of investigational product administration (Day 1) until 7 days after last dosing, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after the last dose of investigational product.

Exclusion criteria

Planned or anticipated to receive a kidney transplant during the study.
Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin (total) greater than 4 × the ULN at screening.
Subjects with severe hepatic impairment (Child-Pugh Class C).
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.
Subject has known hypersensitivity to the study intervention or any component of the investigational product formulation.