The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children
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ClinicalTrials.gov Identifier: NCT02532790 |
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
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Tracking Information | ||||
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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 |
Disappearance of proteinuria [ Time Frame: 30 months ] The proteinuria is < 150mg/d
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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 With Mild Proteinuria in Children | |||
Official Title ICMJE | The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children | |||
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. | |||
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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Henoch-Schoenlein Purpura Nephritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | NCT02532790 | |||
Other Study ID Numbers ICMJE | AiZhang | |||
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 |
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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 |