Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028171
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-12-17
Brief Title:
Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients Once Daily Versus Twice Daily Dosing
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients Once Daily Versus Twice Daily Dosing
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tacrolimus is a medication given to transplant patients to help prevent rejection The purpose of this study is to see if tacrolimus can be taken once a day instead of twice a day in kidney transplant patients
Transplant patients are required to take several medications to prevent rejection and to treat complications after their transplantation Because of the complicated dosing schedule it can be difficult for patients to follow their medication schedule Taking fewer medications less frequently may help transplant patients to better manage their drug therapy
Tacrolimus is better absorbed in the body if it is taken in the morning than if it is taken in the evening This suggests that tacrolimus can be taken once every morning instead of twice daily in order to produce appropriate drug exposure to prevent organ rejection without increased side effects
Transplant patients are required to take several medications to prevent rejection and to treat complications after their transplantation Because of the complicated dosing schedule it can be difficult for patients to follow their medication schedule Taking fewer medications less frequently may help transplant patients to better manage their drug therapy
Tacrolimus is better absorbed in the body if it is taken in the morning than if it is taken in the evening This suggests that tacrolimus can be taken once every morning instead of twice daily in order to produce appropriate drug exposure to prevent organ rejection without increased side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: