Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis

NCT ID: NCT03222687

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2017-05-31

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.

Conditions

Henoch-Schönlein Purpura Nephritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

therapy group

Immunosuppressive therapy included tacrolimus and prednisone.

Group Type: EXPERIMENTAL

tacrolimus

Intervention Type: DRUG

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.

prednisone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

-

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Zhao

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Other Identifiers

2017TAC001

Identifier Type: -

Identifier Source: org_study_id