Minimal change disease
Conditions
Interventions
Experimental group:Prednisolone combined with rituximab
Control group:Prednisolone only
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65; 2. Minimal change disease confirmed by renal biopsy; 3. 24h-UTP>3.5g/24h, and serum albumin=60ml/min/1.73m2; 5. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Rituximab used in the past 6 months, Cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil or leflunomide have been used in the past 3 months; 2. Prednisolone has been used in the past 3 months (except that the dosage of prednisolone <= 10mg/d); 3. Acute renal injury or renal vein thromboembolism occurred in the past month; 4. Active infection, active tuberculosis, HBsAg positive or HBV-DNA showing virus replication, HCV antibody positive, HIV infection; 5. Pregnant or lactating women, women who refuse contraception; 6. Have a history of malignant tumor in the past 2 years; 7. Allergic to humanized monoclonal antibodies; 8. ALT or AST is 2 times higher than the upper limit of normal; 9. Have been vaccinated with live vaccine in the past month; 10. Participated in other clinical trials in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein quantitation;Serum albumin;eGFR;The number and proportion of patients who achieved complete response (CR) or partial response (PR) after 18 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved remission (CR or PR) after 3, 6, 12, and 24 months of treatment;Proportion of patients with recurrent nephrotic syndrome after 3, 6, 12, and 24 months of treatment; | — |
Countries
China
Contacts
Public ContactMinghui Zhao
Peking University First Hospital
Outcome results
None listed