MMF After Pediatric Liver Transplantation

Sponsor

Hannover Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT00367146

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation Chronic Kidney Disease	Drug: MMF	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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