Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy

Launched by FIRST AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Aug 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called rituximab, either alone or combined with corticosteroids, for treating a kidney condition known as primary membranous nephropathy (PMN). The trial involves 78 patients who are randomly assigned to receive either the combination treatment or rituximab on its own. Over six months, the researchers will monitor how well each treatment works, particularly looking for a significant drop in protein levels in the urine, which is a sign of improved kidney function.

To participate, patients must be between 18 and 75 years old and have been diagnosed with PMN through a kidney biopsy. They should have already tried certain blood pressure medications for at least three months without success. However, those with certain other health issues, like diabetes or previous treatments for PMN, may not be eligible. Participants can expect regular check-ups and assessments to track their progress over a 12-month period. It's important for potential participants to understand the requirements and procedures fully, and they will need to provide informed consent before joining the trial.

Gender

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Eligibility criteria

• • Inclusion Criteria
• • 1. Men and women aged 18-75 years;
• • 2. Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy;
• 3. After treatment with ACE inhibitors or ARBs for at least 3 months, the following two points were met (unless intolerance to ACE inhibitors or ARBs, contraindications, hypotension that may cause side effects, or the investigator judged that the patient was not suitable for RAS inhibitors):
• • (1) Those who have an average 24-hour urine protein ≥ 3.5g twice a week, or an average 24-hour urine protein ≥ 5g twice in 14 days, the requirement of RASi for at least 3 months is not required (2) Blood pressure≤ 130/80mmHg, 4. Glomerular filtration rate (eGFR) ≥30mL/min/1.73m2 (calculated according to the CKD-EPI formula) 5. If female, must be postmenopausal or postoperatively infertile or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease); 6. Subjects voluntarily signed the informed consent form;
• Exclusion Criteria:
• • 1. Patients with type 1 diabetes mellitus or type 2 diabetes mellitus complicated with diabetic nephropathy. Patients with a recent history of steroid-induced diabetes were eligible if renal biopsies show no evidence of secondary diabetic nephropathy within 6 months before the screening period
• • 2. Patients with secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
• • 3. Previous treatment with rituximab, steroids, alkylating agents, calcineurin inhibitors, synthetic ACTH, mycophenolate (MMF), and azathioprine;
• • 4. Receipt of any other study medication (within the last month);
• • 5. Suspected or known allergy or immune reaction to rituximab, corticosteroids or any of their components (including excipients);
• • 6. Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.
• • 7. A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation;
• • 8. Females with a positive pregnancy screening test or lactating or planning to become pregnant in the next 24 months. Female or male patients who were unwilling to use contraceptive methods throughout the study;
• • 9. A history of mental illness;
• 10. Laboratory tests that meet the following criteria need to be excluded:
• • (1) Hemoglobin\<80g/L; (2) Platelet \< 80×109/L; (3) Neutrophil \<1.0×109/L; (4) Aspartate aminotransferase (AST) or amino aminotransferase (ALT) \> 2.5× upper limit of normal except in relation to the primary disease; 11. Very high-risk patients: presenting with life-threatening nephrotic syndrome, or unexplained rapid deterioration of renal function 12. Any patient judged by the investigator to be unsuitable for inclusion in the trial.