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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
Full description
A: Study group
FK506-MMF.
Immunosupression protocol:
Metylprednisolon 10 mg/kg intraoperatively i.v.
FK506 Day 0 or 1 oraly (0,15 mg/kg/D in two doses).
MMF max. dosage 30 mg/kg/D p.o. day 0 through day 90 according to patient condition and therapeutic MMF blood concentration
Tailoring:
Immunosupression protocol will be tailored according to the cause of liver failure: patients with autoimmune liver disease (autoimmune hepatitis, PBC, PSC, overlap syndrome etc) would be maintained on MMF. All other recipients including cryptogenic liver cirrhosis will be gradually (over 1 month) withdrawn from MMF administration 90 days after transplantation if there is:
Targeted Tacrolimus trough levels:
Month 1 - 3 through levels 10-15 ng/ml Month 4-6 10-12 ng/ml Month 7-12 10 - 6 ng/ml
Rejection treatment:
Concomitant drugs:
Antiviral and antibacterial prophylaxis according to current centre praxis. Prophylaxis of cholestasis and prophylaxis/treatment of the bone disease where applicable.
B. Control group
Tacrolimus, steroids.
Immunosupression protocol:
Metylprednisolon 10 mg/kg bm intraoperatively Children < 25kg bm: Metylprednisolon taper from 100 mg/D on day 0 to MP 10 mg on day 7 Children > 25kg bm: Metylprednisolon taper from 200 mg/D on day 0 to MP 20 mg on day 7 Week 2-4 Prednison - 0,5-0,3 mg/kg/D Week 4-12 Prednison -0,3-0,2 mg/kg/D Month 4-6 Prednison 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).
Intended Tacrolimus trough levels:
Month 1 -3 through levels 10-15 ng/ml Month 4-6 10-12 ng/ml Month 7-12 6-10 ng/ml
Rejection treatment:
Biopsy: Liver biopsy should be taken in any suspicion of graft rejection or disease recurrence. Protocol biopsy would be taken according to local practice, liver biopsy in one-year after transplantation is mandatory.
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
Inclusion criteria:
Subjects who meet all of the following criteria are eligible for this study:
Exclusion criteria:
Subjects who meet one or more of the following criteria are not eligible for this study:
Informed Consent:
Patient, who will give written consent for participation in the study and will fulfil all the inclusion and exclusion criteria, will be included in the study. After inclusion into the study, the patient may withdraw at any time for any reason.
Follow-up: (time of one patient observation ) -12 months
Number of centers: 1 Number of patients: 40 Indication: - Primary Liver transplantation Duration of study: 36 months Enrollment period: 18 months
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Inclusion criteria
Subjects who meet all of the following criteria are eligible for this study:
Exclusion criteria
Subjects who meet one or more of the following criteria are not eligible for this study:
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Data sourced from clinicaltrials.gov
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