PK of MMF in Cadaveric vs Living Donor Liver Transplant Recipients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 0,1, 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 Design
Outcome Measures
Primary Outcome Measures
- Comparison of Pharmacokinetics of MMF in living donor liver transplant and deceased donor liver transplant []
Secondary Outcome Measures
- Comparison of Pharmacokinetics of IV MMF vs PO MMF []
- Pharmacokinetics of tacrolimus after liver transplant []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult
-
Female patients
-
Negative pregnancy test
-
Willing for contraception during the study period and 6 weeks after study
Exclusion Criteria:
-
Serum Creatinine > 2.5 mg/dl
-
On Dialysis
-
HIV +ve
-
Re-transplantation
-
On Ventilator
-
Multi-organ Transplant
-
Platelets < 50,000
-
WBC < 2,500
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
- Hoffmann-La Roche
Investigators
- Principal Investigator: Ashok Jain, MD, University of Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RSRB 10410
- CEL 458