A Phase 4 interventional study of tacrolimus and prednisone in Henoch-Schönlein Purpura Nephritis, sponsored by Shandong University. Completed. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-07-19.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
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.
Shandong University is the lead sponsor of 291 studies on the registry; 59 are open to participants now.
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HSPN children Aged less than 18 years; receiving tacrolimus as initial immunosuppressive therapy -
Exclusion Criteria:
Children received other immunosuppressive drug before the trial or other systemic trial drug therapy; Children had a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
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Immunosuppressive therapy included tacrolimus and prednisone.
Drug: tacrolimus · Drug: prednisone
Immunosuppressive therapy included tacrolimus and prednisone. Tacrolimus treatment was initiated at a dosage of 0.05-0.1 mg/kg/day twice daily and used for at least 6 month. Prednisone was started at 2 mg/kg/day and tapered off gradually after initiation of treatment.
Immunosuppressive therapy included tacrolimus and prednisone. Tacrolimus treatment was initiated at a dosage of 0.05-0.1 mg/kg/day twice daily and used for at least 6 month. Prednisone was started at 2 mg/kg/day and tapered off gradually after initiation of treatment.
Complete remission
clinical symptoms and signs disappeared and proteinuria was less than 4mg/h per m2 body surface area within 6 months.
Time frame: within 6 months
Partial remission
if proteinuria was reduced to 4.1-40mg/h per m2 body surface area within 6 months. A nonresponsive patient was defined if there was no improvement in clinical symptoms or signs 6 months after the therapy of tacrolimus with or without prednisone, or urinary protein remained more than 40mg/h per m2 body surface area.
Time frame: within 6 months
nonresponsive
A nonresponsive patient was defined if there was no improvement in clinical symptoms or signs 6 months after the therapy of tacrolimus with or without prednisone, or urinary protein remained more than 40mg/h per m2 body surface area.
Time frame: within 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2015 to primary completion in May 2017, 20 months.
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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tacrolimus