Clinical trial

Obinutuzumab in the Management of Idiopathic Membranous Nephropathy

Name
Obinutuzumab-IMN
Description
To observe the efficacy and safety of obinutuzumab in Chinese population with idiopathic membranous nephropathy and guide clinical management.
Trial arms
Trial start
2023-07-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Not yet recruiting
Treatment
Obinutuzumab Injection
1000mg intravenous injection
Arms:
Non-response, Response
Other names:
Obinutuzumab
Size
30
Primary endpoint
Remission
6 months
Eligibility criteria
Inclusion Criteria: 1. Clinical diagnosis of nephrotic syndrome. 2. The diagnosis of IMN was confirmed by renal biopsy pathology (light and electron microscopy) or if the serum pla2r antibody was greater than 20 IU / ml. 3. Those who have failed glucocorticoid therapy combined with cyclophosphamide or other immunosuppressive agents or rituximab, or have recurrent relapses. 4. Treatment with inotuzumab. Exclusion Criteria: 1. Patients with positive HBV serologic markers (HBsAg or / and HBeAg), HCV positivity, or abnormal liver function tests (alt, AST, or bilirubin more than 2 times the upper limit of normal and persistently elevated for 2 weeks). 2. Patients with congenital or acquired immunodeficiency, or combined infections such as active tuberculosis, active CMV, etc. Patients with CO morbid severe infections requiring intravenous antibiotics. 3. Patients with other serious physical or psychological diseases. 4. Patients with congenital heart disease, arrhythmia, heart failure and other severe cardiovascular disease, tumor.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-05-10

1 organization

1 product

1 indication