- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02532790
The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Aihua Zhang, M.D.
- Phone Number: +8618951769017
- Email: bszah@163.com
Study Contact Backup
- Name: Yimei Wu
- Phone Number: +8615951757930
- Email: wym891203@163.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Recruiting
- Nanjing Children's Hospital
-
Contact:
- Aihua Zhang, M.D.
- Phone Number: +8618951769017
- Email: bszah@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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)
|
0.2-0.3mg/kg/d
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disappearance of proteinuria
Time Frame: 30 months
|
The proteinuria is < 150mg/d
|
30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disappearance of hematuria
Time Frame: 30 months
|
The number of red blood cells is < 3 in each high power field of vision
|
30 months
|
Renal function
Time Frame: 30 months
|
The glomerular filtration rate is normal
|
30 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Aihua Zhang, M.D., Department of Nephrology, Nanjing children's hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Kidney Diseases
- Urologic Diseases
- Urological Manifestations
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Urination Disorders
- Hemostatic Disorders
- Vasculitis
- Hypersensitivity
- Blood Coagulation Disorders
- Skin Manifestations
- Immune Complex Diseases
- Proteinuria
- Purpura
- Nephritis
- Purpura, Schoenlein-Henoch
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- AiZhang
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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