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

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ClinicalTrials.gov Identifier: NCT00309218
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : April 23, 2015
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Dr. med. Britta Hoecker, Klinik für Kinder- und Jugendmedizin

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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Drug: methylprednisolone Phase 3

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After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : March 1999
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Number of patients who were deprived of steroids successfully [ Time Frame: 24 months ]
  2. Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months [ Time Frame: 24 months ]
  3. Incidence and severity of steroid side effects [ Time Frame: 24 months ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
ClinicalTrials.gov Identifier: NCT00309218     History of Changes
Other Study ID Numbers: BToenshoff001
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by Dr. med. Britta Hoecker, 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
Cyclosporins
Cyclosporine
Mycophenolic Acid
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents