NCT05885763

Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Vifor Fresenius Medical Care Renal Pharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-26
• Primary completion: 2023-10-09
• Completion: 2023-10-09
• First posted: 2023-06-02
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

4 sites across 1 country: China