Comparison of Immunosuppression Protocols After LTx in Children

NCT00195988 | Completed Phase 4

• 1 other identifier: IDS-CZD-piokal
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Liver Transplantation

Keywords

immunosuppression,; steroid avoidance,; liver transplantation,; children

Outcome Measures

Primary Outcomes (1)

• Number of rejections, number of steroid-resistant rejections.

Secondary Outcomes (5)

• 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

Interventions

tacrolimus, steroids, mycophenolate mofetil DRUG

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects who meet all of the following criteria are eligible for this study:
• Male or female patients, not older than 18 years old.
• Primary liver transplantation
• 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

You may not qualify if:

• Subjects who meet one or more of the following criteria are not eligible for this study:
• Female patients who are pregnant or are breast feeding
• Patients \> 18 years old
• Combined liver-kidney transplantation
• Recipient of second liver graft
• Patients are allergic, hyper-sensitive or intolerant to HCO-60 or structurally related compounds, macrolide antibiotics or tacrolimus.
• Patients with known HIV-anamnesis
• Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for another indication than the prophylaxis of liver graft rejection
• Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer.
• 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.
• 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)

Sponsors & Collaborators

• Children's Memorial Health Institute, Poland: lead

Study Sites (1)

Department of Pediatric Surgery and Organ Transplantation, CMHI

Warsaw, 04-743, Poland

Location

MeSH Terms

Interventions

Tacrolimus; Steroids; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Fused-Ring Compounds; Polycyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Piotr Kalicinski, Prof., MD, PhD

  Children's Memorial Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2002
• Study Completion: July 1, 2006
• Last Updated: November 17, 2005

Record last verified: 2005-06

Locations

PL (1)