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NCT00367146 Clinical Trial

MMF After Pediatric Liver Transplantation

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00367146
Other study ID # MHH3474MMF
Secondary ID
Status Completed
Phase N/A
First received August 21, 2006
Last updated May 19, 2011
Start date November 2004
Est. completion date August 2008

Study information
Verified date July 2007
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• MMF

Locations
Country Name City State
Germany Hannover medical School Hannover

Sponsors (1)
Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections 1, 3, 6, 9, 12, 24 month Yes
Secondary incidence of chronic kidney disease 12, 24 month No
Secondary incidence of infections 1, 3, 6, 9, 12, 24 month No
Secondary incidence of ptld (post transplant lymphoproliferative disease) 1, 3, 6, 9, 12, 24 month No
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