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.
Comparing efficacy \& safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
198
Unnamed facility
Brussels, Belgium
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
Time frame: 6 months
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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
oral
Unnamed facility
Leuven, Belgium
Unnamed facility
Prague, Czechia
Unnamed facility
Lyon, France
Unnamed facility
Nantes, France
Unnamed facility
Paris, France
Unnamed facility
Berlin, Germany
Unnamed facility
Cologne, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Heidelberg, Germany
...and 25 more locations