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Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis

NCT03222687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-07-19

No results posted yet for this study

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.

Conditions

  • Henoch-Schönlein Purpura Nephritis

Interventions

DRUG

tacrolimus

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.

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.

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Principal Investigators

  • Wei Zhao · Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03222687 on ClinicalTrials.gov