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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Klinik für Kinder- und Jugendmedizin.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Klinik für Kinder- und Jugendmedizin
ClinicalTrials.gov Identifier:
NCT00309218
First received: March 30, 2006
Last updated: August 20, 2009
Last verified: August 2009
  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 3

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

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After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
University Children's Hospital
Heidelberg, Germany, 69120
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

No publications provided

ClinicalTrials.gov Identifier: NCT00309218     History of Changes
Other Study ID Numbers: BToenshoff001
Study First Received: March 30, 2006
Last Updated: August 20, 2009
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

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

ClinicalTrials.gov processed this record on October 21, 2014