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Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

Primary Purpose

End Stage Renal Disease on Hemodialysis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Difelikefalin Injection
Sponsored by
Vifor Fresenius Medical Care Renal Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Hemodialysis focused on measuring Difelikefalin, Pharmacokinetics

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator Site 1Recruiting
  • Investigator Site 2Recruiting
  • Investigator Site 3Recruiting
  • Investigator Site 4Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1-week, single arm, open label treatment phase

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the PK profile of difelikefalin - Cmax
Cmax = Maximum (peak) observed plasma concentration
Evaluation of the PK profile of difelikefalin - Tmax
Tmax = Time to reach maximum observed plasma concentration
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"
AUCinf
AUCinf = AUC from time zero to infinity
AUCextrap(%)
AUCextrap(%) = percentage of AUCinf based on extrapolation
t½ = elimination half-life
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
Vz
Vz = volume of distribution

Secondary Outcome Measures

Full Information

First Posted
May 17, 2023
Last Updated
September 20, 2023
Sponsor
Vifor Fresenius Medical Care Renal Pharma
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05885763
Brief Title
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Fresenius Medical Care Renal Pharma
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Hemodialysis
Keywords
Difelikefalin, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
A Single-arm, Open-label Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1-week, single arm, open label treatment phase
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Difelikefalin Injection
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of the PK profile of difelikefalin - Cmax
Description
Cmax = Maximum (peak) observed plasma concentration
Time Frame
1 week
Title
Evaluation of the PK profile of difelikefalin - Tmax
Description
Tmax = Time to reach maximum observed plasma concentration
Time Frame
1 week
Title
Evaluation of the PK profile of difelikefalin - AUC0-t
Description
AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"
Time Frame
1 week
Title
AUCinf
Description
AUCinf = AUC from time zero to infinity
Time Frame
1 week
Title
AUCextrap(%)
Description
AUCextrap(%) = percentage of AUCinf based on extrapolation
Time Frame
1 week
Title
Description
t½ = elimination half-life
Time Frame
1 week
Title
Clearance
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
Time Frame
1 week
Title
Vz
Description
Vz = volume of distribution
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KOR-CHINA-101 Clinical Study Team
Phone
+41 58 851 80 00
Email
kor-china-101.study@viforpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milica Enoiu, PhD
Organizational Affiliation
Vifor Pharma Group
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 1
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 2
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 3
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 4
City
Shijiazhuang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

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