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Trial · Interventional

CompletedPhase 1Results postedRegistry data

Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

NCTNCT05885763 (opens ClinicalTrials.gov in a new tab)Other idKOR-CHINA-101Other idJXHL2101166
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
30 participants (actual)
Sponsor
Vifor Fresenius Medical Care Renal Pharma · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
26 Jun 2023
Primary completion
9 Oct 2023
Completion
9 Oct 2023
First posted
2 Jun 2023
Last update posted
14 Feb 2025
Conditions
End Stage Renal Disease on Hemodialysis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph 1

    Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

    NCT05885763

    26 Jun 2023 to 9 Oct 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Difelikefalin InjectionDrug

Arms1

  • Experimental

    1-week, single arm, open label treatment phase

Primary outcomes14

Outcomes the sponsor listed as primary.

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

    Time frame · 1 week

    Registry description

    Cmax = Maximum (peak) observed plasma concentration

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

    Time frame · 1 week

    Registry description

    Tmax = Time to reach maximum observed plasma concentration

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

    Time frame · 1 week

    Registry description

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

  4. AUCinf - Dose 1

    Time frame · 1 week

    Registry description

    AUCinf = AUC from time zero to infinity

  5. AUCextrap(%) - Dose 1

    Time frame · 1 week

    Registry description

    AUCextrap(%) = percentage of AUCinf based on extrapolation

  6. t½ - Dose 1

    Time frame · 1 week

    Registry description

    t½ = elimination half-life

  7. Clearance - Dose 1

    Time frame · 1 week

    Registry description

    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

    Registry description

    Vz = volume of distribution

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

    Time frame · 1 week

    Registry description

    Cmax = Maximum (peak) observed plasma concentration

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

    Time frame · 1 week

    Registry description

    Tmax = Time to reach maximum observed plasma concentration

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

    Time frame · 1 week

    Registry description

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

  12. AUCinf - Dose 3

    Time frame · 1 week

    Registry description

    AUCinf = AUC from time zero to infinity

  13. AUCextrap(%) - Dose 3

    Time frame · 1 week

    Registry description

    AUCextrap(%) = percentage of AUCinf based on extrapolation

  14. t½ - Dose 3

    Time frame · 1 week

    Registry description

    t½ = elimination half-life

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· 1 week

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

GroupValue (ng/mL)Spread
1-week, Single Arm, Open Label Treatment Phase3.7033.1
Primary outcomeMedian· 1 week

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

GroupValue (Hours)
1-week, Single Arm, Open Label Treatment Phase0.08
Primary outcomeGeometric mean· 1 week

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

GroupValue (h*ng/mL)Spread
1-week, Single Arm, Open Label Treatment Phase48.327.6
Primary outcomeGeometric mean· 1 week

AUCinf - Dose 1

GroupValue (h*ng/mL)Spread
1-week, Single Arm, Open Label Treatment Phase63.243.9
Primary outcomeGeometric mean· 1 week

AUCextrap(%) - Dose 1

GroupValue (percentage)Spread
1-week, Single Arm, Open Label Treatment Phase23.549.3
Primary outcomeGeometric mean· 1 week

t½ - Dose 1

GroupValue (Hours)Spread
1-week, Single Arm, Open Label Treatment Phase22.236.4
Primary outcomeGeometric mean· 1 week

Clearance - Dose 1

GroupValue (L/H)Spread
1-week, Single Arm, Open Label Treatment Phase0.51043.6
Primary outcomeGeometric mean· 1 week

Vz - Dose 1

GroupValue (L)Spread
1-week, Single Arm, Open Label Treatment Phase16.320.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1-week, Single Arm, Open Label Treatment PhaseDifelikefalin 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.0 / 302 / 3011 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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