End Stage Renal Disease on HemodialysisPhase 1NCT05885763
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
A Phase 1 study testing Difelikefalin Injection in people with End Stage Renal Disease on Hemodialysis, run by Vifor Fresenius Medical Care Renal Pharma at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease on Hemodialysis
- What is being tested?
- Difelikefalin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 26 Jun 2023to 9 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Investigator Site 1
Beijing
Investigator Site 2
Beijing
Investigator Site 3
Beijing
Investigator Site 4
Shijiazhuang
About this study
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
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.
Read the 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
- Being tested
- Difelikefalin Injection
- Keywords
- Difelikefalin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difelikefalin InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1-week, single arm, open label treatment phase | Experimental | Not described Receives: Drug: Difelikefalin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1
Cmax = Maximum (peak) observed plasma concentration
Measured: 1 week
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1
Tmax = Time to reach maximum observed plasma concentration
Measured: 1 week
Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 1
AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"
Measured: 1 week
AUCinf - Dose 1
AUCinf = AUC from time zero to infinity
Measured: 1 week
AUCextrap(%) - Dose 1
AUCextrap(%) = percentage of AUCinf based on extrapolation
Measured: 1 week
t½ - Dose 1
t½ = elimination half-life
Measured: 1 week
Clearance - Dose 1
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
Measured: 1 week
Vz - Dose 1
Vz = volume of distribution
Measured: 1 week
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3
Cmax = Maximum (peak) observed plasma concentration
Measured: 1 week
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3
Tmax = Time to reach maximum observed plasma concentration
Measured: 1 week
Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 3
AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"
Measured: 1 week
AUCinf - Dose 3
AUCinf = AUC from time zero to infinity
Measured: 1 week
AUCextrap(%) - Dose 3
AUCextrap(%) = percentage of AUCinf based on extrapolation
Measured: 1 week
t½ - Dose 3
t½ = elimination half-life
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start26 Jun 2023
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal Disease on HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Single-arm, Open-label Study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Milica Enoiu, PhD, Study director, Vifor Pharma Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885763
- Sponsor's protocol ID
- KOR-CHINA-101
- Other IDs
- JXHL2101166
- Status last verified
- Feb 2025
- First submitted
- 17 May 2023
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05885763
- Acronym / sponsor ID
- KOR-CHINA-101
- Conditions
- End Stage Renal Disease on Hemodialysis
- Keywords
- Difelikefalin, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vifor Fresenius Medical Care Renal PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Posted 14 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Single-arm, Open-label Study
| Arm | Type | Receives |
|---|---|---|
| 1-week, single arm, open label treatment phase | Experimental | Drug: Difelikefalin Injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difelikefalin InjectionParticipants 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. | Drug | 1-week, single arm, open label treatment phase |
Primary outcome
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1
Time frame: 1 week
Cmax = Maximum (peak) observed plasma concentration
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1
Time frame: 1 week
Tmax = Time to reach maximum observed plasma concentration
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"
AUCinf - Dose 1
Time frame: 1 week
AUCinf = AUC from time zero to infinity
AUCextrap(%) - Dose 1
Time frame: 1 week
AUCextrap(%) = percentage of AUCinf based on extrapolation
t½ - Dose 1
Time frame: 1 week
t½ = elimination half-life
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
Vz - Dose 1
Time frame: 1 week
Vz = volume of distribution
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3
Time frame: 1 week
Cmax = Maximum (peak) observed plasma concentration
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3
Time frame: 1 week
Tmax = Time to reach maximum observed plasma concentration
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"
AUCinf - Dose 3
Time frame: 1 week
AUCinf = AUC from time zero to infinity
AUCextrap(%) - Dose 3
Time frame: 1 week
AUCextrap(%) = percentage of AUCinf based on extrapolation
t½ - Dose 3
Time frame: 1 week
t½ = elimination half-life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milica Enoiu, PhD study director
Vifor Pharma Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Difelikefalin Injection in people with End Stage Renal Disease on Hemodialysis, run by Vifor Fresenius Medical Care Renal Pharma at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1 (time frame: 1 week). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.