PK of MMF in Cadaveric vs Living Donor Liver Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178425
First received: September 12, 2005
Last updated: April 18, 2007
Last verified: April 2007
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00178425     History of Changes
Other Study ID Numbers: RSRB 10410, CEL 458
Study First Received: September 12, 2005
Last Updated: April 18, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014