Minimal Change Disease
Conditions
Interventions
Observation group:None
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old, gender unrestricted; 2. Primary minimal change disease (MCD) confirmed by kidney biopsy; 3. Clinical manifestations consistent with nephrotic syndrome (proteinuria >=3.5g/24 hours, serum albumin <30g/L); 4. Voluntary signed informed consent;
Exclusion criteria
Exclusion criteria: 1. Kidney biopsy shows pathological changes other than MCD; 2. Concurrent diseases that make participation unsuitable, such as: severe cardiac disease, malignant tumors, connective tissue diseases, immunodeficiency disorders; 3. Presence of active infections, including: Active Hepatitis B (HBV): Positive HBsAg and HBV-DNA above detection limit during screening; If regular antiviral treatment reduces HBV-DNA to below detection limit, patient may be included; HBsAg negative, but Anti-HBc positive patients require preventive antiviral treatment; Active Hepatitis C (HCV): Positive HCV-Ab and HCV-RNA during screening Active Tuberculosis: Evidence of active TB infection within the past year HIV infection: Positive HIV antibody test 4. eGFR < 30 ml/min/1.73m²; 5. Allergy to Obinutuzumab; 6. Vaccination with live vaccine within 4 weeks prior to study initiation; 7. Contraindicated or strongly inadvisable for Obinutuzumab treatment as determined by the treating physician; 8. Pregnant, breastfeeding, planning pregnancy within 1 year, or unwilling to use contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Clinical Remission Rate at 8 Weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Remission Rate at 8 Weeks, and Complete and Partial Remission Rates at 24 and 48 Weeks;Median Time to Remission (Complete Remission and Partial Remission);Relapse-Free Proportion at Week 48;Median Relapse-Free Time;Variations in CD19+ and CD20+ Cell Counts;Variations in eGFR and Quantitative Urinary Protein Levels;Adverse Event Rate; | — |
Countries
China
Contacts
Public ContactXu Ricong
Shenzhen Second People's Hospital
Outcome results
None listed