Clinical trial NCT00309218: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Diseases
Keywords: Pediatric renal transplantation
Steroid withdrawal
Mycophenolate Mofetil
Cyclosporine A
Stable graft function
children
renal transplantation
Lead sponsor: Klinik für Kinder- und Jugendmedizin
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-03-31
Enrollment: 42
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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

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

Primary outcomes:
measure: Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)
timeFrame: 24 months
Secondary outcomes:
measure: Number of patients who were deprived of steroids successfully
timeFrame: 24 months
measure: Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months
timeFrame: 24 months
measure: Incidence and severity of steroid side effects
timeFrame: 24 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany
name: Burkhard Toenshoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: