NCT00178425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

September 12, 2005

Last Update Submit

April 18, 2007

Conditions

Transplantation, Liver

Keywords

mycophenolate mofetil hydrochloridepharmacokineticstacrolimus

Outcome Measures

Primary Outcomes (1)

  • Comparison of Pharmacokinetics of MMF in living donor liver transplant and deceased donor liver transplant

Secondary Outcomes (2)

  • Comparison of Pharmacokinetics of IV MMF vs PO MMF

  • Pharmacokinetics of tacrolimus after liver transplant

Interventions

Serial blood sampling as described in protocolPROCEDURE
Estimation of Creatinine Clearance at regular intervalsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult
  • Female patients
  • Negative pregnancy test
  • Willing for contraception during the study period and 6 weeks after study

You may not qualify if:

  • Serum Creatinine \> 2.5 mg/dl
  • On Dialysis
  • HIV +ve
  • Re-transplantation
  • On Ventilator
  • Multi-organ Transplant
  • Platelets \< 50,000
  • WBC \< 2,500

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Ashok Jain, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 2005

Study Completion

June 1, 2006

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

US(1)