Comparison of Immunosuppression Protocols After LTx in Children - Full Text View

Sponsor:	Children's Memorial Health Institute, Poland
Information provided by:	Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:	NCT00195988

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: High Blood Pressure Liver Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

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

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

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mycophenolic Acid

Mycophenolate mofetil
Enzyme Inhibitors
Tacrolimus
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010