Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00296348

Purpose

The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.

Condition	Intervention	Phase
Kidney Transplantation	Drug: tacrolimus Drug: mycophenolate mofetil Drug: daclizumab Drug: steroids	Phase III

MedlinePlus related topics: Kidney Transplantation

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open, Randomised, Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus, Mycophenolate Mofetil and Daclizumab Against Tacrolimus, Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute rejection: Incidence of and time to first biopsy proven acute rejection; overall frequency of acute rejections episodes; incidence of and time to first corticosteroid-resistant rejection; severity of biopsy-proven acute rejections (Banff97 criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	198
Study Start Date:	November 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: tacrolimus immunosuppression Drug: mycophenolate mofetil oral Drug: steroids oral
2: Experimental	Drug: tacrolimus immunosuppression Drug: mycophenolate mofetil oral Drug: daclizumab oral

Detailed Description:

Comparing efficacy & safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patient younger than 18 but not younger than 2 years of age
Skeletal age of boys < or = 17, girls < or = 15 years
Patient has end stage kidney disease
Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter.
The patient, or in case the patient is a minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent

Exclusion Criteria:

Patient has a most recently measured panel reactive antibody (PRA) grade of > or = 50%
Patient is allergic to or intolerant of study medication
Patient and/or donor is known to be HIV positive.
Patient has significant liver disease
Patient with malignancy or history of malignancy
Patient has previously received or is receiving an organ transplant other than kidney.
Patient has been previously enrolled in this study.
Patient with the relapsing and non-diarrhoeal form of haemolytic uraemic syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296348

Show 35 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Medical Physician

Astellas Pharma Europe

More Information

Link to FDA website This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG-506-02-43
Study First Received:	February 23, 2006
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00296348
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:

Tacrolimus
Kidney Transplantation
Child
Treatment Outcome
Immunosuppression

Study placed in the following topic categories:

Daclizumab
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus

Additional relevant MeSH terms:

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

Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009