Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF) - Tabular View

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Tracking Information

First Received Date ^†

March 30, 2006

Last Updated Date

August 30, 2006

Start Date ^†

March 1999

Current Primary Outcome Measures ^†

Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00309218 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Number of patients who were deprived of steroids successfully
Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months
Incidence and severity of steroid side effects

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)

Official Title ^†

Multicenter, Open-Label, Randomized Study on Steroid-Free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)

Brief Summary

The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.

Detailed Description

The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase):

Branch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization

Branch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day

After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Kidney Diseases

Intervention ^†

Drug: methylprednisolone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

May 2010

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Age < 18.0 years
Bone age of boys < 15 years, of girls < 13 years
Patients 12-24 months after renal transplantation with stable transplant function
First or second kidney transplant, living or cadaver kidney donation
Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry
Patients and parents, respectively, have given their written consent after enlightenment (informed consent)

Exclusion Criteria:

Irreversible rejection of former transplant within 6 months
Highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
Anamnestically steroid-resistant rejection of current transplant
More than 2 acute rejection reactions prior to study entry (i.e., in the first 12–24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
Glomerular filtration rate (GFR) < 40 ml/min/1.73 m² (Schwartz formula) at study entry
Acute rejection reaction or unstable transplant function (increase of serum creatinine > 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
Suspected insufficient medication compliance
Patients receiving a basic immunosuppression other than that prescribed in this protocol
Simultaneous therapy with growth hormone after renal transplantation

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Britta Hoecker, MD	++49-6221-5638360	Britta_Hoecker@med.uni-heidelberg.de
Contact: Burkhard Toenshoff, MD, PhD	++49-6221-568401	Burkhard_Toenshoff@med.uni-heidelberg.de

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309218

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Klinik für Kinder- und Jugendmedizin

Collaborators ^††

Hoffmann-La Roche

Investigators ^†

Principal Investigator:

Burkhard Toenshoff, MD, PhD

University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany

Information Provided By

Klinik für Kinder- und Jugendmedizin

Verification Date

March 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.