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The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children

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ClinicalTrials.gov Identifier: NCT02532790
Recruitment Status : Recruiting
First Posted : August 26, 2015
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Aihua Zhang, Nanjing Children's Hospital

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

Condition or disease Intervention/treatment Phase
Henoch-Schoenlein Purpura Nephritis Drug: Prednisone Drug: ACEI 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 markers 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 randomized to receive either prednisone p.o. or angiotensin-converting enzyme inhibitor(ACEI) p.o. We will follow up them for about 2.5 years and compare the efficacy and safety of both measures by monitoring several indexes.


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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 With Mild Proteinuria 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


Arm Intervention/treatment
Experimental: group 1
Prednisone Drug : prednisone 1.5mg/kg/d for 4-6 weeks, then 1.5mg/kg/d qod for 4 weeks, reduce 5mg every 2-4 weeks If the proteinuria decreases by less than 50% after treating for two months, this candidate reaches the ending point.
Drug: Prednisone
1.5mg/kg/d

Experimental: group 2
Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
Drug: ACEI
0.2-0.3mg/kg/d
Other Name: Lotensin




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


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

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



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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 (ISKDC class II)
  • Proteinuria < 25 mg/kg/d

Exclusion Criteria:

  • The children with congenital diseases
  • Proteinuria≥25 mg/kg/d

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): NCT02532790


Contacts
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Contact: Aihua Zhang, 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

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Responsible Party: Aihua Zhang, Hospital vice president, Nanjing Children's Hospital
ClinicalTrials.gov Identifier: NCT02532790     History of Changes
Other Study ID Numbers: AiZhang
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Keywords provided by Aihua Zhang, Nanjing Children's Hospital:
Mild proteinuria
Additional relevant MeSH terms:
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Nephritis
Proteinuria
Purpura, Schoenlein-Henoch
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases
Prednisone
Benazepril
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal