- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00178425
PK of MMF in Cadaveric vs Living Donor Liver Transplant Recipients
Pharmacokinetics of Intravenous / Oral MMF and Oral Tacrolimus in Live Donor and Deceased Donor Liver Transplant Patients
Study Overview
Status
Conditions
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 Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Comparison of Pharmacokinetics of MMF in living donor liver transplant and deceased donor liver transplant
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Secondary Outcome Measures
Outcome Measure |
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Comparison of Pharmacokinetics of IV MMF vs PO MMF
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Pharmacokinetics of tacrolimus after liver transplant
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashok Jain, MD, University of Rochester
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RSRB 10410
- CEL 458
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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