Comparison of Immunosuppression Protocols After LTx in Children

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Memorial Health Institute, Poland
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Subjects who meet all of the following criteria are eligible for this study:

1. Male or female patients, not older than 18 years old.

2. Primary liver transplantation

3. Patient is capable of understanding the purpose and risks of the study and has been informed both orally and in writing and has given informed consent

Exclusion Criteria:

• Subjects who meet one or more of the following criteria are not eligible for this study:

1. Female patients who are pregnant or are breast feeding

2. Patients > 18 years old

3. Combined liver-kidney transplantation

4. Recipient of second liver graft

5. Patients are allergic, hyper-sensitive or intolerant to HCO-60 or structurally related compounds, macrolide antibiotics or tacrolimus.

6. Patients with known HIV-anamnesis

7. Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for another indication than the prophylaxis of liver graft rejection

8. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer.

9. Patient is participating or has participated in another clinical study and/or is taking or has been taking an investigational drug in the past 28 days.

10. Other reasons which depend on the assessment of the physician (no MMF will be given to patients with severe persistent hypersplenism (WBC < 3.500/ml, platelets < 50.000/ml)