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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

Study Description
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Brief Summary:
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

Condition or disease Intervention/treatment Phase
Henoch-Schoenlein Purpura Nephritis Drug: Prednisone Drug: Cyclophosphamide(CTX) Drug: Mycophenolate mofetil(MMF) Drug: Leflunomide(LEF) Drug: Angiotensin-converting enzyme inhibitor(ACEI) Drug: Methylprednisolone Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
Study Start Date : August 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 Drug: Prednisone
Drug: Cyclophosphamide(CTX)
Drug: Angiotensin-converting enzyme inhibitor(ACEI)
Other Name: Lotensin

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.

 Drug: Prednisone
Drug: Mycophenolate mofetil(MMF)
Drug: Angiotensin-converting enzyme inhibitor(ACEI)
Other Name: Lotensin

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.

 Drug: Prednisone
Drug: Leflunomide(LEF)
Drug: Angiotensin-converting enzyme inhibitor(ACEI)
Other Name: Lotensin

Drug: Methylprednisolone


Outcome Measures
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Primary Outcome Measures :
  1. Disappearance of proteinuria [ Time Frame: 30 mo ]
    The proteinuria is < 150mg/d


Secondary Outcome Measures :
  1. Disappearance of hematuria [ Time Frame: 30 mo ]
    The number of red blood cells is < 3 in each high power field of vision

  2. Renal function [ Time Frame: 30 mo ]
    The glomerular filtration rate is normal


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • The children with congenital diseases Proteinuria < 50 mg/kg/d
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532777


Contacts
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Contact: Aihua Aihua, M.D. +8618951769017 bszah@163.com
Contact: Yimei Wu +8615951757930 wym891203@163.com

Locations
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China, Jiangsu
Nanjing Children's Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Aihua Zhang, M.D.    +8618951769017    bszah@163.com   
Sponsors and Collaborators
Nanjing Children's Hospital
Investigators
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Study Chair: Aihua Zhang, M.D. Department of Nephrology, Nanjing children's hospital
More Information
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Responsible Party: Aihua Zhang, Hospital vice president, Nanjing Children's Hospital
ClinicalTrials.gov Identifier: NCT02532777    
Other Study ID Numbers: AZhang
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Nephritis
Purpura, Schoenlein-Henoch
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Kidney Diseases
Urologic Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
 Immune Complex Diseases
Hypersensitivity
Immune System Diseases
Mycophenolic Acid
Prednisone
Methylprednisolone
Cyclophosphamide
Leflunomide
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating