Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
Recruitment status was Active, not recruiting
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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) |
- Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)
- 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 |
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After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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 |
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| Germany | |
| University Children's Hospital | |
| Heidelberg, Germany, 69120 | |
| 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 Cyclosporins Cyclosporine Mycophenolic Acid Mycophenolate mofetil Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013