Registry of IgA Nephropathy in Chinese Children (RACC)

Peking University

Status: Enrolling

Conditions: Immunosuppressive Treatment; Proteinuria in Nephrotic Range; IgA Nephropathy

Treatments: Drug: Dipyridamole; Drug: Cyclophosphamide; Drug: ACE Inhibitor or Angiotensin receptor antagonist; Drug: Corticosteroid; Drug: Mycophenolate mofetil

Study type: Observational

Funder types: Other

Identifiers

NCT03015974

2015[992]

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

In-patients will be enrolled with the following criteria.

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.

Trial design

1,200 participants in 3 patient groups

corticosteroid

Description:

pediatric IgA nephropathy treated with only corticosteroid

Treatment:

Drug: ACE Inhibitor or Angiotensin receptor antagonist

Drug: Corticosteroid

Drug: Dipyridamole

corticosteroid and cyclophosphamide

Description:

pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide

Treatment:

Drug: ACE Inhibitor or Angiotensin receptor antagonist

Drug: Corticosteroid

Drug: Dipyridamole

Drug: Cyclophosphamide

corticosteroid and mycophenolate mofetil

Description:

pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil

Treatment:

Drug: ACE Inhibitor or Angiotensin receptor antagonist

Drug: Mycophenolate mofetil

Drug: Corticosteroid

Drug: Dipyridamole