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Rituximab in the treatment of refractory membranous nephropathy: a multicenter, randomized, controlled clinical study

Rituximab in the treatment of resistant membranous nephropathy: a multicenter, randomized, controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008527
Enrollment
Unknown
Registered
2016-05-24
Start date
2016-06-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Membranous nephropathy

Interventions

CsA group:oral CsA and glucosteroid
RTX group:intravenous RTX
CTX:Intravenous cyclophosphamide and glucosteroid

Sponsors

Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, male or female; 2. Membranous nephropathy proved by renal pathology; 3. Eliminate secondary membranous nephropathy (HBV, HCV, malignant tumor, SLE, autoimmune disease or drug associated MN); 4. EPI-GFR >= 30ml/min; 5. Sign informed consent; 6. 24h proteinuria >= 4g/d and serum albumia < 30g/L despite 3 months treatment with maximum tolerated doses of ACEI and/or ARB.

Exclusion criteria

Exclusion criteria: 1. Patients already used RTX; 2. Allergic to investigational drug; 3. Recent operation plan; 4. Severe acute or chronic infection (sepsis, respiratory/urinary/digestive infection), or patients receiving antibiotic treatment; 5. Severe cardiac lesion, NYHA III-IV; 6. Presist WBC 2 times of normal range);or HBV-DNA positive; 10. Newly diagnosed malignant tumor or patients receiving radiotherapy/chemotherapy; 11. Sever edema; 12. Condition unstable to receive the treatment.

Design outcomes

Primary

MeasureTime frame
Complete or Partial remission;

Secondary

MeasureTime frame
relapse;eGFR;death;thrombosis/embolism complication;

Countries

China

Contacts

Public ContactChen Nan

Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicine

cnrj100@126.com+86 13601638963

Outcome results

None listed

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