Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT04102943
The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Phase 4
Seoul, South Korea
This study is a Single center, randomized, open-label, Phase IV study to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) administration for 24 Weeks in patients after renal transplantation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: tacrobell tablet
Other names: prograf capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Chong Kun Dang Pharmaceutical
Industry
Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.
Acronym: PK-TACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07700563
Antibody Mediated Rejection, BK Virus Nephropathy
View Trial DetailsNCT05456243
Kidney Transplant
Rochester, Minnesota, United States
View Trial DetailsNCT07621835
CMV Reactivation, CMV Specific Immune Response
Córdoba, Spain
View Trial DetailsNCT04969757
Kidney Transplant
Paris, France
View Trial Details