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A Multicenter Prospective Randomized Controlled Study of Glucocorticoids in Combination With Anti-CD20 Monoclonal Antibodies in Adults With Minimal Change Nephropathy

A Multicenter Prospective Randomized Controlled Study of Glucocorticoids in Combination With Anti-CD20 Monoclonal Antibodies in Adults With Minimal Change Nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103108
Enrollment
Unknown
Registered
2025-05-23
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Minimal change disease

Interventions

Experimental group:Initially half of the glucocorticoid (orally taken at the beginning 0.5 mg/kg/d and decreased within 12 weeks) combined with anti-CD20 monoclonal antibody (1000 mg, intravenous drop
Control group:Treatment with adequate glucocorticoids (oral treatment at the beginning of 1mg/kg/d, with a minimum of 24 weeks of reduced suspension).

Sponsors

Shanghai East Hospital (South Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years (inclusive); 2. The clinical manifestation is nephrotic syndrome 3. Voluntarily sign the informed consent form; 4. Pathologically confirmed diagnosis of "minimal change nephropathy" through renal biopsy without immunosuppressive therapy;

Exclusion criteria

Exclusion criteria: 1. Allergy to glucocorticoids, anti-CD20 monoclonal antibodies, or inability to tolerate medications: 2. Secondary minimal change nephropathy (drugs, infections, tumors, etc.) or combined with other primary or secondary glomerular diseases; 3. Relapsed/refractory minimal change nephropathy; 4. Have used any kind of immunosuppressant within half a year; 5. Combined with diabetes mellitus; 6. Active hepatitis, cirrhosis, abnormal liver function such as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) 2-3 times the upper limit of normal, total bilirubin more than 2 times the upper limit of normal; 7. Have severe active infection, HIV infection, active tuberculosis; 8. Combined malignant tumors 9. History of acute myocardial infarction within three months before entering the study, history of major surgical trauma within three months, etc.; 10. Pregnant and lactating females, or those who cannot guarantee effective contraception during childbearing age; 11. Those who suffer from mental disorders and take psychotropic drugs; 12. The doctor assessed that the patient was not easy to follow up or had poor compliance; 13. Patients who are unwilling to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Urine protein quantification;Renal function ;Serum albumin;Liver function;

Countries

China

Contacts

Public ContactNa Liu

Shanghai East Hospital

naliubrown@163.com+86 182 1776 8587

Outcome results

None listed

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