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PK of MMF in Cadaveric vs Living Donor Liver Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178425
First Posted: September 15, 2005
Last Update Posted: April 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Rochester
  Purpose
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 Intervention Phase
Transplantation, Liver Procedure: Serial blood sampling as described in protocol Procedure: Estimation of Creatinine Clearance at regular intervals Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Intravenous / Oral MMF and Oral Tacrolimus in Live Donor and Deceased Donor Liver Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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

Estimated Enrollment: 24
Study Start Date: January 2005
Study Completion Date: June 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178425


Locations
United States, New York
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
  More Information

ClinicalTrials.gov Identifier: NCT00178425     History of Changes
Other Study ID Numbers: RSRB 10410
CEL 458
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: April 19, 2007
Last Verified: April 2007

Keywords provided by University of Rochester:
mycophenolate mofetil hydrochloride
pharmacokinetics
tacrolimus

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action