Back to resultsMMF After Pediatric Liver Transplantation
Primary Purpose
Liver Transplantation, Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MMF
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation focused on measuring liver transplantation, children, immunosuppression, mycophenolatmofetil, calcineurin inhibitor, kidney disease
Eligibility Criteria
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)
Sites / Locations
- Hannover medical School
Outcomes
Primary Outcome Measures
safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections
Secondary Outcome Measures
incidence of chronic kidney disease
incidence of infections
incidence of ptld (post transplant lymphoproliferative disease)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00367146
Brief Title
MMF After Pediatric Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Chronic Kidney Disease
Keywords
liver transplantation, children, immunosuppression, mycophenolatmofetil, calcineurin inhibitor, kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MMF
Primary Outcome Measure Information:
Title
safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections
Time Frame
1, 3, 6, 9, 12, 24 month
Secondary Outcome Measure Information:
Title
incidence of chronic kidney disease
Time Frame
12, 24 month
Title
incidence of infections
Time Frame
1, 3, 6, 9, 12, 24 month
Title
incidence of ptld (post transplant lymphoproliferative disease)
Time Frame
1, 3, 6, 9, 12, 24 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Melter, PhD, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
MMF After Pediatric Liver Transplantation
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