The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children

NCT ID: NCT02532790

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Henoch-Schoenlein Purpura Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

1.5mg/kg/d

group 2

Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)

Group Type EXPERIMENTAL

ACEI

Intervention Type DRUG

0.2-0.3mg/kg/d

Interventions

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Prednisone

1.5mg/kg/d

Intervention Type DRUG

ACEI

0.2-0.3mg/kg/d

Intervention Type DRUG

Other Intervention Names

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Lotensin

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aihua Zhang

Hospital vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aihua Zhang, M.D.

Role: STUDY_CHAIR

Department of Nephrology, Nanjing children's hospital

Locations

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Nanjing Children's Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Aihua Zhang, M.D.

Role: CONTACT

+8618951769017

Yimei Wu

Role: CONTACT

+8615951757930

Facility Contacts

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Aihua Zhang, M.D.

Role: primary

+8618951769017

References

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Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.

Reference Type DERIVED
PMID: 36853224 (View on PubMed)

Other Identifiers

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AiZhang

Identifier Type: -

Identifier Source: org_study_id

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