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Efficacy and safety of Enteric-coated mycophenolate sodium in IgA nephropathy with activity proliferative lesions

Efficacy and safety of Enteric-coated mycophenolate sodium in IgA nephropathy with activity proliferative lesions

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060990
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

IgA nephropathy

Interventions

Group 1:semi hormone combined with Enteric-coated mycophenolate sodium
Group 2: semi hormone

Sponsors

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Biopsy proven IgAN within 1 month before enrollment; 2. At least 1 of the following histologic lesions: cellular and fibrocellular crescents involving 10% to 50% of glomeruli, endocapillary hypercellularity, or glomerular necrosis; 3. Aged 18 to 65 years; 4. Urinary protein excretion no less than 1.0 g/24 h on 2 consecutive measurements within 1 week; 5. eGFR >= 60 ml/min/1.73m2.

Exclusion criteria

Exclusion criteria: Secondary IgA nephropathy, crescentic glomerulonephritis, IgA nephropathy with inactive proliferative lesions, eGFR<60 Ml /min/1.73m^2, pregnant or breastfeeding, malignant tumor, hepatitis B virus carrier, active tuberculosis, severe liver function impairment (ALT is 2 times or more of the upper limit of normal reference value), severe immune deficiency or severe cardiopulmonary function impairment.

Design outcomes

Primary

MeasureTime frame
The rate of complete remission;

Secondary

MeasureTime frame
response rate;Absolute drop of eGFR;Total incidence of adverse reactions;

Countries

China

Contacts

Public ContactJun JIANG

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

j361527372@126.com+86 13855157348

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026