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Clinical Trial Details

Trial ID: L1044
Source ID: NCT05885763
Associated Drug: Difelikefalin Injection
Title: Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05885763/results
Conditions: End Stage Renal Disease on Hemodialysis
Interventions: DRUG: Difelikefalin Injection
Outcome Measures: Primary: 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|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 |
Sponsor/Collaborators: Sponsor: Vifor Fresenius Medical Care Renal Pharma | Collaborators: Tigermed Consulting Co., Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-26
Completion Date: 2023-10-09
Results First Posted: 2025-02-14
Last Update Posted: 2025-02-14
Locations: Investigator Site 1, Beijing, China|Investigator Site 2, Beijing, China|Investigator Site 3, Beijing, China|Investigator Site 4, Shijiazhuang, China
URL: https://clinicaltrials.gov/show/NCT05885763

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress