Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis
Status:
Completed
Trial end date:
2017-05-31
Target enrollment:
Participant gender:
Summary
Henoch-Schönlein purpura (HSP) is the most common vasculitis in children, with an incidence
of approximately 10:100 000 children and a slight male predominance (male-to-female ratio of
1.5:1). Henoch-Schönlein purpura nephritis (HSPN) is the principal cause of morbidity for HSP
and 1%-7% of HSPN patients may progress to renal failure or end-stage renal disease.
Immunosuppressive therapy has become the standard treatment in children with HSPN, however
the use of these drugs are still mainly in an off-label manner in clinical practice.
Tacrolimus, a calcineurin inhibitor, has been recently suggested in the treatment of HSPN in
children. However, the evidence-based clinical data are still limited.
Given the potential benefits and unmet need in clinical practice, the purposes of this pilot
study were to assess effectiveness and safety of tacrolimus in HSPN children and evaluate the
potential impact of CYP3A5.