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Comparison of Immunosuppression Protocols After LTx in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195988
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 17, 2005
Sponsor:
Information provided by:
Children's Memorial Health Institute, Poland

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


Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: tacrolimus, steroids, mycophenolate mofetil Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2002
Study Completion Date : July 2006





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

Secondary Outcome Measures :
  1. Patients and graft survival
  2. Dyslipidemia one year after transplantation
  3. Hypertension one year after transplantation
  4. Hyperglycemia/Diabetes de novo one year after transplantation
  5. Renal function before Tx and 1 year after Tx


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

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


Locations
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Poland
Department of Pediatric Surgery and Organ Transplantation, CMHI
Warsaw, Poland, 04-743
Sponsors and Collaborators
Children's Memorial Health Institute, Poland
Investigators
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Principal Investigator: Piotr Kalicinski, Prof., MD, PhD Children's Memorial Health Institute
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ClinicalTrials.gov Identifier: NCT00195988    
Other Study ID Numbers: IDS-CZD-piokal
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 17, 2005
Last Verified: June 2005
Keywords provided by Children's Memorial Health Institute, Poland:
immunosuppression,
steroid avoidance,
liver transplantation,
children
Additional relevant MeSH terms:
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Mycophenolic Acid
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents