The Research of Standard Diagnosis and Treatment for HSPN in Children

Henoch-Schoenlein Purpura Nephritis Clinical Trial

Official title:

The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02532777
• Other study ID #: AZhang
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Nanjing Children's Hospital
• Contact: Aihua Aihua, M.D.
• Phone: +8618951769017
• Email: bszah[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• The children with congenital diseases Proteinuria < 50 mg/kg/d

Related Conditions & MeSH terms

• Henoch-Schoenlein Purpura Nephritis
• Nephritis
• Purpura
• Purpura, Schoenlein-Henoch

Intervention

Drug:
• Prednisone

• Cyclophosphamide(CTX)

• Mycophenolate mofetil(MMF)

• Leflunomide(LEF)

• Angiotensin-converting enzyme inhibitor(ACEI)

• Methylprednisolone

Locations

Country	Name	City	State
China	Nanjing Children's Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disappearance of proteinuria	The proteinuria is < 150mg/d	30 mo
Secondary	Disappearance of hematuria	The number of red blood cells is < 3 in each high power field of vision	30 mo
Secondary	Renal function	The glomerular filtration rate is normal	30 mo