Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

End Stage Renal Disease on Hemodialysis Clinical Trial

Official title:

A Phase 1, Single-arm, Open-label Study to Evaluate the Pharmacokinetics and Safety of Intravenous Difelikefalin in Adult Chinese Subjects on Haemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05885763
• Other study ID #: KOR-CHINA-101
• Secondary ID: JXHL2101166
• Status: Completed
• Phase: Phase 1
• Start date: June 26, 2023
• Est. completion date: October 9, 2023

Study information

• Verified date: June 2024
• Source: Vifor Fresenius Medical Care Renal Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 9, 2023
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease on Hemodialysis
• Kidney Failure, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Investigator Site 1	Beijing
China	Investigator Site 2	Beijing
China	Investigator Site 3	Beijing
China	Investigator Site 4	Shijiazhuang

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Fresenius Medical Care Renal Pharma	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the PK profile of difelikefalin - Cmax	Cmax = Maximum (peak) observed plasma concentration	1 week
Primary	Evaluation of the PK profile of difelikefalin - Tmax	Tmax = Time to reach maximum observed plasma concentration	1 week
Primary	Evaluation of the PK profile of difelikefalin - AUC0-t	AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"	1 week
Primary	AUCinf	AUCinf = AUC from time zero to infinity	1 week
Primary	AUCextrap(%)	AUCextrap(%) = percentage of AUCinf based on extrapolation	1 week
Primary	t½	t½ = elimination half-life	1 week
Primary	Clearance	Clearance = the volume of blood or plasma that can be freed of a specified constituent in a specified time by its excretion into the urine through the kidneys	1 week
Primary	Vz	Vz = volume of distribution	1 week