Comparison of Immunosuppression Protocols After LTx in Children
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|ClinicalTrials.gov Identifier: NCT00195988|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 17, 2005
Open label, randomised, prospective, onecentre Investigator Driven Study:
Comparison of two protocols of immunosuppression after liver Tx in children:
A: Study group - FK506-MMF. Immunosupression protocol: Methylprednisolone 10 mg/kg intraoperatively i.v. FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).MMF max. dosage 30 mg/kg/D p.o. day 0 through day 90.
B. Control group - Tacrolimus, steroids. Immunosupression protocol: Methylprednisolone 10 mg/kg bm intraoperatively Children < 25kg bm: Methylprednisolone taper from 100 mg/D on day 0 to MP 10 mg on day 7 Children > 25kg bm: Methylprednisolone taper from 200 mg/D on day 0 to MP 20 mg on day 7 Week 2-4 Prednisone - 0,5-0,3 mg/kg/D; Week 4-12 Prednisone -0,3-0,2 mg/kg/D; Month 4-6 Prednisone 0,2 - 0,1 mg/kg/D Month 7 - Steroid withdrawal FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).
Primary end points:
Number of rejections, number of steroid-resistant rejections.
Secondary end points:
Patients and graft survival Dyslipidemia one year after transplantation Hypertension one year after transplantation Hyperglycemia/Diabetes de novo one year after transplantation Renal function before Tx and 1 year after Tx
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation||Drug: tacrolimus, steroids, mycophenolate mofetil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Of Efficacy Of Two Immunosuppressive Protocols Including Tacrolimus With Or Without Mycophenolate Mofetil In Pediatric Liver Transplantation Aimed In Early Termination Of Steroid Therapy|
|Study Start Date :||September 2002|
|Study Completion Date :||July 2006|
- Number of rejections, number of steroid-resistant rejections.
- Patients and graft survival
- Dyslipidemia one year after transplantation
- Hypertension one year after transplantation
- Hyperglycemia/Diabetes de novo one year after transplantation
- Renal function before Tx and 1 year after Tx
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195988
|Department of Pediatric Surgery and Organ Transplantation, CMHI|
|Warsaw, Poland, 04-743|
|Principal Investigator:||Piotr Kalicinski, Prof., MD, PhD||Children's Memorial Health Institute|