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

Sponsors and Collaborators:	Klinik für Kinder- und Jugendmedizin Hoffmann-La Roche
Information provided by:	Klinik für Kinder- und Jugendmedizin
ClinicalTrials.gov Identifier:	NCT00309218

Purpose

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.

Condition	Intervention	Phase
Kidney Diseases	Drug: methylprednisolone	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Methylprednisolone Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Klinik für Kinder- und Jugendmedizin:

Primary Outcome Measures:

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

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

Estimated Enrollment:	40
Study Start Date:	March 1999
Estimated Study Completion Date:	May 2010

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After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309218

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

Locations

Germany
University Children's Hospital	Recruiting
Heidelberg, Germany, 69120
Contact: Britta Hoecker, MD ++49-6221-5638360 Britta_Hoecker@med.uni-heidelberg.de
Contact: Burkhard Toenshoff, MD, PhD ++49-6221-562311 Burkhard_Toenshoff@med.uni-heidelberg.de
Sub-Investigator: Uwe Querfeld, MD, PhD
Sub-Investigator: Wolfgang Rascher, MD, PhD
Sub-Investigator: Martin Pohl, MD, PhD
Sub-Investigator: Lars Pape, MD, PhD
Sub-Investigator: Joachim Misselwitz, MD, PhD
Sub-Investigator: Günter Klaus, MD, PhD
Sub-Investigator: Henry Fehrenbach, MD
Sub-Investigator: Stefan Fründ, MD
Sub-Investigator: Lutz Weber, MD, PhD

Sponsors and Collaborators

Klinik für Kinder- und Jugendmedizin

Hoffmann-La Roche

Investigators

Principal Investigator:

Burkhard Toenshoff, MD, PhD

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

More Information

Study ID Numbers:	BToenshoff001
Study First Received:	March 30, 2006
Last Updated:	August 30, 2006
ClinicalTrials.gov Identifier:	NCT00309218
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinik für Kinder- und Jugendmedizin:

Pediatric renal transplantation
Steroid withdrawal
Mycophenolate Mofetil
Cyclosporine A

Stable graft function
children
renal transplantation

Study placed in the following topic categories:

Cyclosporine
Methylprednisolone
Clotrimazole
Miconazole
Tioconazole
Mycophenolic Acid
Methylprednisolone acetate

Prednisolone acetate
Cyclosporins
Urologic Diseases
Prednisolone
Mycophenolate mofetil
Kidney Diseases
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Neuroprotective Agents
Hormones
Therapeutic Uses
Antifungal Agents

Dermatologic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Enzyme Inhibitors
Immunosuppressive Agents
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009