MMF After Pediatric Liver Transplantation

Not Applicable

Completed

• Conditions: Liver Transplantation; Chronic Kidney Disease

• Registration Number: NCT00367146
• Lead Sponsor: Hannover Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-21
• Study First Posted: 2006-08-22
• Status Verified: 2007-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Last Update Submitted: 2011-05-19
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
incidence of ptld (post transplant lymphoproliferative disease)	1, 3, 6, 9, 12, 24 month
incidence of infections	1, 3, 6, 9, 12, 24 month
incidence of chronic kidney disease	12, 24 month

Trial Locations

Locations (1)

Hannover medical School; 🇩🇪 Hannover, Germany