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Completed

NCT Number: NCT05885763

Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

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.

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Key information

Conditions

End Stage Renal Disease on Hemodialysis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site 1, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Is surgically sterile; or
  • Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or
  • 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.

Treatment and study plan

Difelikefalin Injection

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.

Primary outcomes

  1. Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1

    Time frame: 1 week

    Cmax = Maximum (peak) observed plasma concentration

  2. Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1

    Time frame: 1 week

    Tmax = Time to reach maximum observed plasma concentration

  3. Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 1

    Time frame: 1 week

    AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"

  4. AUCinf - Dose 1

    Time frame: 1 week

    AUCinf = AUC from time zero to infinity

  5. AUCextrap(%) - Dose 1

    Time frame: 1 week

    AUCextrap(%) = percentage of AUCinf based on extrapolation

  6. t½ - Dose 1

    Time frame: 1 week

    t½ = elimination half-life

  7. Clearance - Dose 1

    Time frame: 1 week

    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

  8. Vz - Dose 1

    Time frame: 1 week

    Vz = volume of distribution

  9. Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3

    Time frame: 1 week

    Cmax = Maximum (peak) observed plasma concentration

  10. Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3

    Time frame: 1 week

    Tmax = Time to reach maximum observed plasma concentration

  11. Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 3

    Time frame: 1 week

    AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"

  12. AUCinf - Dose 3

    Time frame: 1 week

    AUCinf = AUC from time zero to infinity

  13. AUCextrap(%) - Dose 3

    Time frame: 1 week

    AUCextrap(%) = percentage of AUCinf based on extrapolation

  14. t½ - Dose 3

    Time frame: 1 week

    t½ = elimination half-life

Sponsors and collaborators

Lead sponsor

Vifor Fresenius Medical Care Renal Pharma

Industry

Collaborators

  • Tigermed Consulting Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.