Status:
COMPLETED
Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
Lead Sponsor:
Klinik für Kinder- und Jugendmedizin
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Kidney Diseases
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
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 a...
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00309218
Start Date
March 1 1999
End Date
June 1 2008
Last Update
April 23 2015
Active Locations (1)
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1
University Children's Hospital
Heidelberg, Germany, 69120