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
|Condition or disease||Intervention/treatment||Phase|
|Henoch-Schoenlein Purpura Nephritis||Drug: Prednisone Drug: ACEI||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
Experimental: group 2
Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
Other Name: Lotensin
- Disappearance of proteinuria [ Time Frame: 30 months ]The proteinuria is < 150mg/d
- Disappearance of hematuria [ Time Frame: 30 months ]The number of red blood cells is < 3 in each high power field of vision
- Renal function [ Time Frame: 30 months ]The glomerular filtration rate is normal
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
|Contact: Aihua Zhang, M.D.||+firstname.lastname@example.org|
|Contact: Yimei Wuemail@example.com|
|Nanjing Children's Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: Aihua Zhang, M.D. +8618951769017 firstname.lastname@example.org|
|Study Chair:||Aihua Zhang, M.D.||Department of Nephrology, Nanjing children's hospital|