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| ID | Type | Description | Link |
|---|---|---|---|
| JXHL2101166 | Other Identifier | Center for Drug Evaluation (CDE) China |
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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-week, single arm, open label treatment phase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1 | Cmax = Maximum (peak) observed plasma concentration | 1 week |
| Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1 | Tmax = Time to reach maximum observed plasma concentration | 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" | 1 week |
| AUCinf - Dose 1 | AUCinf = AUC from time zero to infinity | 1 week |
| AUCextrap(%) - Dose 1 | AUCextrap(%) = percentage of AUCinf based on extrapolation | 1 week |
| t½ - Dose 1 | t½ = elimination half-life | 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 | 1 week |
| Vz - Dose 1 | Vz = volume of distribution | 1 week |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Milica Enoiu, PhD | Vifor Pharma Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 1 | Beijing | China | ||||
| Investigator Site 2 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-week, Single Arm, Open Label Treatment Phase | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-week, Single Arm, Open Label Treatment Phase | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1 | Cmax = Maximum (peak) observed plasma concentration | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 week |
|
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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).
The SAE reporting period begins at the time the ICF is signed by the subject. The SAE reporting period ends 30 days following the last study visit. After last study visit, SAEs that comes to the attention of the Investigator must be reported to the CRO/Sponsor and will be documented in the safety database of the Sponsor only and not in eCRF. A rationale for the assessment of a causal relationship must be provided by the Investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-week, Single Arm, Open Label Treatment Phase | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess limb | Skin and subcutaneous tissue disorders | Systematic Assessment | One subject discontinued the study, due to a pre-treatment SAE of abscess limb after receiving only 1 dose of study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Milica Enoiu | CSL Vifor | +41 58 851 82 64 | milica.enoiu@viforpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2021 | Sep 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000657129 | difelikefalin |
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A Single-arm, Open-label Study
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| Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3 | Cmax = Maximum (peak) observed plasma concentration | 1 week |
| Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3 | Tmax = Time to reach maximum observed plasma concentration | 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" | 1 week |
| AUCinf - Dose 3 | AUCinf = AUC from time zero to infinity | 1 week |
| AUCextrap(%) - Dose 3 | AUCextrap(%) = percentage of AUCinf based on extrapolation | 1 week |
| t½ - Dose 3 | t½ = elimination half-life | 1 week |
| Beijing |
| China |
| Investigator Site 3 | Beijing | China |
| Investigator Site 4 | Shijiazhuang | China |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1 | Tmax = Time to reach maximum observed plasma concentration | Posted | Median | Full Range | Hours | 1 week |
|
|
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| Primary | 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" | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 1 week |
|
|
|
| Primary | AUCinf - Dose 1 | AUCinf = AUC from time zero to infinity | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 1 week |
|
|
|
| Primary | AUCextrap(%) - Dose 1 | AUCextrap(%) = percentage of AUCinf based on extrapolation | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage | 1 week |
|
|
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| Primary | t½ - Dose 1 | t½ = elimination half-life | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 1 week |
|
|
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| Primary | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/H | 1 week |
|
|
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| Primary | Vz - Dose 1 | Vz = volume of distribution | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 1 week |
|
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| Primary | Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3 | Cmax = Maximum (peak) observed plasma concentration | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 week |
|
|
|
| Primary | Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3 | Tmax = Time to reach maximum observed plasma concentration | Posted | Median | Full Range | Hours | 1 week |
|
|
|
| Primary | 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" | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 1 week |
|
|
|
| Primary | AUCinf - Dose 3 | AUCinf = AUC from time zero to infinity | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 1 week |
|
|
|
| Primary | AUCextrap(%) - Dose 3 | AUCextrap(%) = percentage of AUCinf based on extrapolation | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage | 1 week |
|
|
|
| Primary | t½ - Dose 3 | t½ = elimination half-life | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 1 week |
|
|
|
| 0 |
| 30 |
| 2 |
| 30 |
| 11 |
| 30 |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
|
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