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Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis

Primary Purpose

Henoch-Schönlein Purpura Nephritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tacrolimus
prednisone
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Henoch-Schönlein Purpura Nephritis focused on measuring tacrolimus, Henoch-Schönlein purpura nephritis, children

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    therapy group

    Arm Description

    Immunosuppressive therapy included tacrolimus and prednisone.

    Outcomes

    Primary Outcome Measures

    Complete remission
    clinical symptoms and signs disappeared and proteinuria was less than 4mg/h per m2 body surface area 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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 7, 2017
    Last Updated
    July 17, 2017
    Sponsor
    Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03222687
    Brief Title
    Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis
    Official Title
    Off-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and Safety
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    May 31, 2017 (Actual)
    Study Completion Date
    May 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shandong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Henoch-Schönlein Purpura Nephritis
    Keywords
    tacrolimus, Henoch-Schönlein purpura nephritis, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    therapy group
    Arm Type
    Experimental
    Arm Description
    Immunosuppressive therapy included tacrolimus and prednisone.
    Intervention Type
    Drug
    Intervention Name(s)
    tacrolimus
    Intervention Description
    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
    Intervention Name(s)
    prednisone
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Complete remission
    Description
    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
    Title
    Partial remission
    Description
    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
    Title
    nonresponsive
    Description
    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

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei Zhao
    Organizational Affiliation
    Shandong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis

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