MMF After Pediatric Liver Transplantation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367146

Enrollment

Registered

2006-08-22

Start date

2004-11-30

Completion date

2008-08-31

Last updated

2011-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Liver Transplantation

Keywords

liver transplantation, children, immunosuppression, mycophenolatmofetil, calcineurin inhibitor, kidney disease

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.

Interventions

DRUGMMF

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026