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The Research of Standard Diagnosis and Treatment for HSPN in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02532777
Recruitment Status : Unknown
Verified February 2020 by Aihua Zhang, Nanjing Children's Hospital.
Recruitment status was:  Recruiting
First Posted : August 26, 2015
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Aihua Zhang, Nanjing Children's Hospital

Tracking Information
First Submitted Date  ICMJE August 20, 2015
First Posted Date  ICMJE August 26, 2015
Last Update Posted Date February 26, 2020
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2015)
Disappearance of proteinuria [ Time Frame: 30 mo ]
The proteinuria is < 150mg/d
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2015)
  • Disappearance of hematuria [ Time Frame: 30 mo ]
    The number of red blood cells is < 3 in each high power field of vision
  • Renal function [ Time Frame: 30 mo ]
    The glomerular filtration rate is normal
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Research of Standard Diagnosis and Treatment for HSPN in Children
Official Title  ICMJE The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
Brief Summary This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
Detailed Description

Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

The patients who are proved to get HSPN by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Henoch-Schoenlein Purpura Nephritis
Intervention  ICMJE
  • Drug: Prednisone
  • Drug: Cyclophosphamide(CTX)
  • Drug: Mycophenolate mofetil(MMF)
  • Drug: Leflunomide(LEF)
  • Drug: Angiotensin-converting enzyme inhibitor(ACEI)
    Other Name: Lotensin
  • Drug: Methylprednisolone
Study Arms  ICMJE
  • Experimental: Prednisone & Cyclophosphamide

    Drug: prednisone & cyclophosphamide & Angiotensin-converting enzyme inhibitor(ACEI).

    Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.

    cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.

    Interventions:
    • Drug: Prednisone
    • Drug: Cyclophosphamide(CTX)
    • Drug: Angiotensin-converting enzyme inhibitor(ACEI)
    • Drug: Methylprednisolone
  • Experimental: Prednisone & Mycophenolate mofetil

    Drug: prednisone & mycophenolate mofetil & Angiotensin-converting enzyme inhibitor(ACEI).

    Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.

    mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.

    Interventions:
    • Drug: Prednisone
    • Drug: Mycophenolate mofetil(MMF)
    • Drug: Angiotensin-converting enzyme inhibitor(ACEI)
    • Drug: Methylprednisolone
  • Experimental: Prednisone & Leflunomide

    Drug: prednisone & leflunomide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.

    Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg),then give the maintaining dose 0.5mg/kg/d.

    Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.

    Interventions:
    • Drug: Prednisone
    • Drug: Leflunomide(LEF)
    • Drug: Angiotensin-converting enzyme inhibitor(ACEI)
    • Drug: Methylprednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 23, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d

Exclusion Criteria:

  • The children with congenital diseases Proteinuria < 50 mg/kg/d
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02532777
Other Study ID Numbers  ICMJE AZhang
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Aihua Zhang, Nanjing Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nanjing Children's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Aihua Zhang, M.D. Department of Nephrology, Nanjing children's hospital
PRS Account Nanjing Children's Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP