Registry of IgA Nephropathy in Chinese Children

NCT ID: NCT03015974

Last Updated: 2023-12-06

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

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2024-12-31

Brief Summary

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This study tries to identify the safe and effective treatment option for IgA nephropathy in children. Investigators will perform prospective registration study among 25 pediatric nephrology medical centers in China.

Detailed Description

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A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide, according to the following protocol.

1. Establishment of registration database online.
2. Participants will be enrolled according to the inclusion criteria and exclusion criteria.
3. The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
4. SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical analysis. P value less than 0.05 will be considered significant.

Conditions

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IgA Nephropathy Proteinuria in Nephrotic Range Immunosuppressive Treatment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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corticosteroid

pediatric IgA nephropathy treated with only corticosteroid

Corticosteroid

Intervention Type DRUG

Dipyridamole

Intervention Type DRUG

ACE Inhibitor or Angiotensin receptor antagonist

Intervention Type DRUG

corticosteroid and cyclophosphamide

pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide

Corticosteroid

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Dipyridamole

Intervention Type DRUG

ACE Inhibitor or Angiotensin receptor antagonist

Intervention Type DRUG

corticosteroid and mycophenolate mofetil

pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil

Corticosteroid

Intervention Type DRUG

Mycophenolate mofetil

Intervention Type DRUG

Dipyridamole

Intervention Type DRUG

ACE Inhibitor or Angiotensin receptor antagonist

Intervention Type DRUG

Interventions

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Corticosteroid

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Mycophenolate mofetil

Intervention Type DRUG

Dipyridamole

Intervention Type DRUG

ACE Inhibitor or Angiotensin receptor antagonist

Intervention Type DRUG

Other Intervention Names

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Steroid Prednisone Methylprednisone Prednisolone Deflazacort CTX MMF

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of primary IgA nephropathy.
* Presenting with nephrotic proteinuria, defined as 24-hour urinary protein\>50mg/kg, or UPC\>2.0 mg/mg.
* Informed consent must be signed.

Exclusion Criteria

* Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing PLA General Hospital

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Shanghai Children's Hospital

OTHER

Sponsor Role collaborator

Nanjing Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Fuzhou General Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Children's Hospital of Hebei Province

OTHER

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Jiangxi Province Children's Hospital

OTHER

Sponsor Role collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role collaborator

Xian Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Capital Institute of Pediatrics, China

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Wuhan Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Tianjin Children's Hospital

OTHER

Sponsor Role collaborator

Chengdu Women's and Children's Central Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Yunnan

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jie Ding

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Ding, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuhui Zhong, Dr.

Role: CONTACT

Phone: 8613683556856

Email: [email protected]

Jie Ding, Prof.

Role: CONTACT

Phone: 861083573238

Email: [email protected]

Facility Contacts

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Xuhui Zhong, Dr.

Role: primary

Other Identifiers

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2015[992]

Identifier Type: -

Identifier Source: org_study_id