- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00309218
Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
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)
Studieöversikt
Detaljerad beskrivning
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After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Heidelberg, Tyskland, 69120
- University Children's Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: A
Steroid withdrawal
|
withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B
|
Placebo-jämförare: B
continuos Steroid treatment
|
withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)
Tidsram: 24 months
|
24 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Number of patients who were deprived of steroids successfully
Tidsram: 24 months
|
24 months
|
Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months
Tidsram: 24 months
|
24 months
|
Incidence and severity of steroid side effects
Tidsram: 24 months
|
24 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Burkhard Toenshoff, MD, PhD, University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urologiska sjukdomar
- Njursjukdomar
- Läkemedels fysiologiska effekter
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Antineoplastiska medel
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Neuroprotektiva medel
- Skyddsmedel
- Prednisolon
- Metylprednisolonacetat
- Metylprednisolon
- Metylprednisolonhemisuccinat
- Prednisolonacetat
- Prednisolonhemisuccinat
- Prednisolonfosfat
Andra studie-ID-nummer
- BToenshoff001
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