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

Study Type

Interventional

Enrollment (Actual)

25

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

No

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

August 21, 2006

First Posted (Estimate)

August 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHH3474MMF

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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