Skip to main content
OpenTrials
Completed

NCT Number: NCT00367146

MMF After Pediatric Liver Transplantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Transplantation Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover medical School

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MMF

Drug

Primary outcomes

  1. safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections

    Time frame: 1, 3, 6, 9, 12, 24 month

Secondary outcomes

  1. incidence of chronic kidney disease

    Time frame: 12, 24 month

  2. incidence of infections

    Time frame: 1, 3, 6, 9, 12, 24 month

  3. incidence of ptld (post transplant lymphoproliferative disease)

    Time frame: 1, 3, 6, 9, 12, 24 month

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2006
Registry last updated
May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.