Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis

Phase 4

Completed

• Conditions: Henoch-Schönlein Purpura Nephritis
• Interventions: Drug: tacrolimus; Drug: prednisone

• Registration Number: NCT03222687
• Lead Sponsor: Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2017-07
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-17
• Last Update Submitted: 2017-07-17
• Study First Posted: 2017-07-19
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy group	tacrolimus	Immunosuppressive therapy included tacrolimus and prednisone.
therapy group	prednisone	Immunosuppressive therapy included tacrolimus and prednisone.

Primary Outcome Measures

Name	Time	Method
nonresponsive	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.
Complete remission	within 6 months	clinical symptoms and signs disappeared and proteinuria was less than 4mg/h per m2 body surface area within 6 months.
Partial remission	within 6 months	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.