Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

NCT ID: NCT05885763

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2023-10-09

Brief Summary

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.

Detailed Description

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.

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.

Conditions

End Stage Renal Disease on Hemodialysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1-week, single arm, open label treatment phase

Group Type: EXPERIMENTAL

Difelikefalin Injection

Intervention Type: DRUG

Participants receive Difelikefalin three times a week (0,5 micrograms/kg dry body weight). Difelikefalin is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.

Interventions

Difelikefalin Injection

Participants receive Difelikefalin three times a week (0,5 micrograms/kg dry body weight). Difelikefalin is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Vifor Fresenius Medical Care Renal Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milica Enoiu, PhD

Role: STUDY_DIRECTOR

Vifor Pharma Group

Locations

Investigator Site 1

Beijing, , China

Investigator Site 2

Beijing, , China

Investigator Site 3

Beijing, , China

Investigator Site 4

Shijiazhuang, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JXHL2101166

Identifier Type: OTHER

Identifier Source: secondary_id

KOR-CHINA-101

Identifier Type: -

Identifier Source: org_study_id