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Comparison of Immunosuppression Protocols After LTx in Children

This study has been completed.
Sponsor:
Information provided by:
Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:
NCT00195988
First received: September 12, 2005
Last updated: November 16, 2005
Last verified: June 2005
History of Changes
  Purpose

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 Intervention Phase
Liver Transplantation
 Drug: tacrolimus, steroids, mycophenolate mofetil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Memorial Health Institute, Poland:

Primary Outcome Measures:
  • Number of rejections, number of steroid-resistant rejections.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: September 2002
Estimated Study Completion Date: July 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195988

Locations
Poland
Department of Pediatric Surgery and Organ Transplantation, CMHI
Warsaw, Poland, 04-743
Sponsors and Collaborators
Children's Memorial Health Institute, Poland
Investigators
Principal Investigator: Piotr Kalicinski, Prof., MD, PhD Children's Memorial Health Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195988     History of Changes
Other Study ID Numbers: IDS-CZD-piokal
Study First Received: September 12, 2005
Last Updated: November 16, 2005
Health Authority: Poland: Ministry of Health

Keywords provided by Children's Memorial Health Institute, Poland:
immunosuppression,
steroid avoidance,
liver transplantation,
children

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013