Rituximab or Cyclophosphamide Combined With Steroids in Idiopathic Membranous Nephropathy

• Status: Not yet recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This wasa prospective, multicenter, randomized, controlled trial. Patients with idiopathic membranous nephropathy (IMN) were randomly divided into intervention or control group. Intervention group was given rituximab combined with steroid in induction therapy. After 6 months, patients in the rituximab treatment group who had decreased 24h urinary protein by >25% but did not achieve CR were given rituximab maintenance therapy. Patients in control group were treated with cyclophosphamide combined with prednisolone.The response rate at 24 months (including the proportion of participants with complete and partial responses at 24 months after enrollment) was measured.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Treatments: Cyclophosphamide; Rituximab

Criteria

Inclusion Criteria:

1. Men and women aged 18-75 years;

2. Patients diagnosed as idiopathic membranous nephropathy (IMN) by renal biopsy within 24 months before enrollment; (3) Proteinuria > 3.5g/d for 3 consecutive days (once a week for 3 consecutive weeks); 4, serum albumin < 35 g/L; 5, assess glomerular filtration rate (eGFR) ≥30ml/min/1.73m2(calculated according to CKD-EPI formula); 6, ACEI or ARB treatment for at least 2 months, blood pressure <140/90 MMHG; 7, if female, must be postmenopausal or postoperative infertility or use of medical contraception (considering the potential risk of thromboembolism in patients with kidney disease); 8, the subject voluntarily signed the informed consent;

Exclusion Criteria:

1. Patients with type 1 diabetes or type 2 diabetes and diabetic nephropathy;

2. Patients with secondary membranous nephropathy and any active infections (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignancy, and other secondary causes, should be tested for HIV, hepatitis B, and C before enrollment);

3. Previous treatment with rituximab, steroids, alkylating agents, calcineurin inhibitors, synthetic ACTH, mycophenolate mofetil (MMF), and azathioprine;

4. Receipt of any other study medication (within the last month);

5. Allergies or a history of allergies to any known interventional drug or any of its components (including excipients);

6. Resistance to rituximab or cyclophosphamide;

7. Presence of active infection;

8. A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation;

9. Pregnancy or lactation; 10, a history of mental illness; 11, laboratory tests meeting the following criteria need to be excluded: （1） Hemoglobin <80g/L; （2） Platelet < 80 x 109/ L; （3） Neutrophil < 1.0×109/ L; （4） Aspartate aminotransferase (AST) or amino acid aminotransferase (ALT) >2.5× upper limit of normal except in relation to the primary disease; 12. Any patient judged by the investigator to be ineligible for enrollment in the trial.