A Phase 1 interventional study of Difelikefalin Injection in End Stage Renal Disease on Hemodialysis, sponsored by Vifor Fresenius Medical Care Renal Pharma. Completed at 4 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Vifor Fresenius Medical Care Renal Pharma (part of CSL Limited) · Phase 1, Interventional, and Treatment
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.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 30 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Vifor Fresenius Medical Care Renal Pharma is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
First submitted after Vifor Fresenius Medical Care Renal Pharma became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If female:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1
Cmax = Maximum (peak) observed plasma concentration
Time frame: 1 week
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1
Tmax = Time to reach maximum observed plasma concentration
Time frame: 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"
Time frame: 1 week
AUCinf - Dose 1
AUCinf = AUC from time zero to infinity
Time frame: 1 week
AUCextrap(%) - Dose 1
AUCextrap(%) = percentage of AUCinf based on extrapolation
Time frame: 1 week
t½ - Dose 1
t½ = elimination half-life
Time frame: 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
Time frame: 1 week
Vz - Dose 1
Vz = volume of distribution
Time frame: 1 week
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3
Cmax = Maximum (peak) observed plasma concentration
Time frame: 1 week
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3
Tmax = Time to reach maximum observed plasma concentration
Time frame: 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"
Time frame: 1 week
AUCinf - Dose 3
AUCinf = AUC from time zero to infinity
Time frame: 1 week
AUCextrap(%) - Dose 3
AUCextrap(%) = percentage of AUCinf based on extrapolation
Time frame: 1 week
t½ - Dose 3
t½ = elimination half-life
Time frame: 1 week
| Milestone | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Started | 30 |
| Completed | 29 |
| Not completed | 1 |
Cmax = Maximum (peak) observed plasma concentration
| ng/mL | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1 | 3.70 ± 33.1 |
Tmax = Time to reach maximum observed plasma concentration
| Hours | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1 | 0.08 (0.05 to 0.98) |
AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"
| h*ng/mL | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 1 | 48.3 ± 27.6 |
AUCinf = AUC from time zero to infinity
| h*ng/mL | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| AUCinf - Dose 1 | 63.2 ± 43.9 |
AUCextrap(%) = percentage of AUCinf based on extrapolation
| percentage | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| AUCextrap(%) - Dose 1 | 23.5 ± 49.3 |
t½ = elimination half-life
| Hours | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| t½ - Dose 1 | 22.2 ± 36.4 |
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
| L/H | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Clearance - Dose 1 | 0.510 ± 43.6 |
Vz = volume of distribution
| L | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Vz - Dose 1 | 16.3 ± 20.4 |
Cmax = Maximum (peak) observed plasma concentration
| ng/mL | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3 | 4.23 ± 23.8 |
Tmax = Time to reach maximum observed plasma concentration
| Hours | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3 | 0.08 (0.05 to 0.57) |
AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"
| h*ng/mL | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 3 | 65.6 ± 33.8 |
AUCinf = AUC from time zero to infinity
| h*ng/mL | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| AUCinf - Dose 3 | 77.6 ± 48.0 |
AUCextrap(%) = percentage of AUCinf based on extrapolation
| percentage | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| AUCextrap(%) - Dose 3 | 15.1 ± 61.4 |
t½ = elimination half-life
| Hours | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| t½ - Dose 3 | 25.0 ± 37.7 |
Collected over Adverse Events (AEs) reported until the last study visit (up to 5 weeks) and Serious AEs (SAEs) until 30 days after the last study visit (up to 10 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1-week, Single Arm, Open Label Treatment Phase | 0/30 (0%) | 2/30 (6.7%) | 11/30 (36.7%) |
| Event | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Abscess limbSkin and subcutaneous tissue disorders | 1/30 |
| SyncopeNervous system disorders | 1/30 |
| Event | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| ParaesthesiaNervous system disorders | 3/30 |
| DizzinessNervous system disorders | 2/30 |
| HyperkalaemiaMetabolism and nutrition disorders | 1/30 |
| HyperlipidaemiaMetabolism and nutrition disorders | 1/30 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 1/30 |
| HypocalcaemiaMetabolism and nutrition disorders | 1/30 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/30 |
| ConstipationGastrointestinal disorders | 1/30 |
| DiarrhoeaGastrointestinal disorders | 1/30 |
| VomitingGastrointestinal disorders | 1/30 |
| Age, Categorical(Participants) | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Female | 8 |
| Male | 22 |
| Race/Ethnicity, Customized(Participants) | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| Chinese | 30 |
| Region of Enrollment(participants) | 1-week, Single Arm, Open Label Treatment Phase |
|---|---|
| China | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2023 to primary completion in Oct 2023, 3 months.
Results were first posted in Feb 2025, 1 year 4 months after primary completion.
Of 46 industry-sponsored phase 1 interventional studies under Kidney Failure, Chronic, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 3 months is below that.
Counting every sponsor, half of 67 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Difelikefalin
Vifor Fresenius Medical Care Renal Pharma →