Kidney Transplantation
Conditions
Keywords
Tacrolimus, Kidney Transplantation, Child, Treatment Outcome, Immunosuppression
Brief summary
The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.
Detailed description
Comparing efficacy & safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.
Interventions
DRUGtacrolimus
immunosuppression
DRUGmycophenolate mofetil
oral
DRUGdaclizumab
oral
DRUGsteroids
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patient younger than 18 but not younger than 2 years of age * Skeletal age of boys \< or = 17, girls \< or = 15 years * Patient has end stage kidney disease * Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter. * The patient, or in case the patient is a minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent
Exclusion criteria
* Patient has a most recently measured panel reactive antibody (PRA) grade of \> or = 50% * Patient is allergic to or intolerant of study medication * Patient and/or donor is known to be HIV positive. * Patient has significant liver disease * Patient with malignancy or history of malignancy * Patient has previously received or is receiving an organ transplant other than kidney. * Patient has been previously enrolled in this study. * Patient with the relapsing and non-diarrhoeal form of haemolytic uraemic syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Acute rejection: Incidence of and time to first biopsy proven acute rejection; overall frequency of acute rejections episodes; incidence of and time to first corticosteroid-resistant rejection; severity of biopsy-proven acute rejections (Banff97 criteria | 6 months |
Countries
Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Romania, South Africa, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Outcome results
None listed