The Research of Standard Diagnosis and Treatment for HSPN in Children

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02532777

Enrollment

100

Registered

2015-08-26

Start date

2015-08-31

Completion date

2020-07-31

Last updated

2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Henoch-Schoenlein Purpura Nephritis

Brief summary

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

Interventions

DRUGPrednisone

DRUGCyclophosphamide(CTX)

DRUGMycophenolate mofetil(MMF)

DRUGLeflunomide(LEF)

DRUGAngiotensin-converting enzyme inhibitor(ACEI)

DRUGMethylprednisolone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

2 Years to 16 Years

Healthy volunteers

Inclusion criteria

* Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Disappearance of proteinuria	30 mo	The proteinuria is \< 150mg/d

Secondary

Measure	Time frame	Description
Disappearance of hematuria	30 mo	The number of red blood cells is \< 3 in each high power field of vision
Renal function	30 mo	The glomerular filtration rate is normal

Countries

China

Contacts

Primary ContactAihua Aihua, M.D.

bszah@163.com+8618951769017

Backup ContactYimei Wu

wym891203@163.com+8615951757930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026