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

This study has been completed.
Hoffmann-La Roche
Information provided by (Responsible Party):
Dr. med. Britta Hoecker, Klinik für Kinder- und Jugendmedizin Identifier:
First received: March 30, 2006
Last updated: April 22, 2015
Last verified: April 2015
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:

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) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients who were deprived of steroids successfully [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence and severity of steroid side effects [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: March 1999
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Steroid withdrawal
Drug: methylprednisolone
withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B
Placebo Comparator: B
continuos Steroid treatment
Drug: methylprednisolone
withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B

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.


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

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
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Please refer to this study by its identifier: NCT00309218

University Children's Hospital
Heidelberg, Germany, 69120
Sponsors and Collaborators
Klinik für Kinder- und Jugendmedizin
Hoffmann-La Roche
Principal Investigator: Burkhard Toenshoff, MD, PhD University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany
  More Information

No publications provided

Responsible Party: Dr. med. Britta Hoecker, Randomized, multicenter trial on steroid withdrawal in pediatric kidney allograft recipients under CsA and MMF, Klinik für Kinder- und Jugendmedizin Identifier: NCT00309218     History of Changes
Other Study ID Numbers: BToenshoff001
Study First Received: March 30, 2006
Last Updated: April 22, 2015
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
renal transplantation

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors processed this record on November 25, 2015