MMF After Pediatric Liver Transplantation

May 19, 2011 updated by: Hannover Medical School

The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term.

The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: MMF

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Hannover, Germany, 30625
    - Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

patients after pediatric liver transplantation
no acute rejections for the last half year

Exclusion Criteria:

concomitant malign disease (e.g. ptld)
neutropenia (granulocytes <1000/µl)
systemic infection
thrombopenia (<80/nl)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections Time Frame: 1, 3, 6, 9, 12, 24 month	1, 3, 6, 9, 12, 24 month

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of chronic kidney disease Time Frame: 12, 24 month	12, 24 month
incidence of infections Time Frame: 1, 3, 6, 9, 12, 24 month	1, 3, 6, 9, 12, 24 month
incidence of ptld (post transplant lymphoproliferative disease) Time Frame: 1, 3, 6, 9, 12, 24 month	1, 3, 6, 9, 12, 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

Principal Investigator: Michael Melter, PhD, MD, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria