Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178425
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2005-09-12
Brief Title:
PK of MMF in Cadaveric vs Living Donor Liver Transplant Recipients
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Pharmacokinetics of Intravenous Oral MMF and Oral Tacrolimus in Live Donor and Deceased Donor Liver Transplant Patients
Status:
COMPLETED
Status Verified Date:
2007-04
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:
The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time Currently MMF is ordered as a set dose and tacrolimus is given based on body weight While the deceased donor transplant receives the complete liver in the live donor just over half of the liver is given about 60 The way these different types of transplants break down drugs could be different Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose
Detailed Description:
The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time Currently MMF is ordered as a set dose and tacrolimus is given based on body weight While the deceased donor transplant receives the complete liver in the live donor just over half of the liver is given about 60 The way these different types of transplants break down drugs could be different Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose
12 subjects with live liver donors and 12 subjects with deceased donors will be included in the study
Each patient will have 12 twelve blood samples half a teaspoon drawn at 01 2 3 4 4½ 5 6 7 8 10 and 12 hours from an intravenous line placed during the operation At the same time 24-hour urine will be collected to measure your kidney function After 4 to 6 days post transplant when the will be switched to oral MMF again 10 ten blood samples a half teaspoon each will be drawn at 0 1 2 3 4 5 6 8 10 12 hours Blood will be drawn with the routine daily blood work for the first 14 days and then at 1 and 3 months after transplant Total blood drawn over 3 months will be about 7 tablespoons A 24-hour urine will be collected in a container given to you starting one day before the routine clinic visit as a standard of care The 24-hour urine will be collected at 1 and 3 months after transplant as well
If a woman who could become pregnant a pregnancy test will be done before your transplant They would also have to use birth control during the study period and 6 months after the completion of study
12 subjects with live liver donors and 12 subjects with deceased donors will be included in the study
Each patient will have 12 twelve blood samples half a teaspoon drawn at 01 2 3 4 4½ 5 6 7 8 10 and 12 hours from an intravenous line placed during the operation At the same time 24-hour urine will be collected to measure your kidney function After 4 to 6 days post transplant when the will be switched to oral MMF again 10 ten blood samples a half teaspoon each will be drawn at 0 1 2 3 4 5 6 8 10 12 hours Blood will be drawn with the routine daily blood work for the first 14 days and then at 1 and 3 months after transplant Total blood drawn over 3 months will be about 7 tablespoons A 24-hour urine will be collected in a container given to you starting one day before the routine clinic visit as a standard of care The 24-hour urine will be collected at 1 and 3 months after transplant as well
If a woman who could become pregnant a pregnancy test will be done before your transplant They would also have to use birth control during the study period and 6 months after the completion of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CEL 458 | None | None | None |