Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial

• Status: Not yet recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

1. Main purpose:

To evaluate the efficacy and safety of rituximab combined with tacrolimus in the treatment of intermediate and high-risk primary membranous nephropathy

2. Secondary research purposes:

To describe the survival of patients with intermediate and high-risk primary membranous nephropathy treated with rituximab combined with tacrolimus; To describe renal survival in patients with intermediate and high-risk primary membranous nephropathy treated with rituximab combined with tacrolimus;

3. Exploratory research purposes:

Feasibility of glucocorticoids-free therapy (rituximab combined with tacrolimus) in the treatment of intermediate and high-risk primary membranous nephropathy

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Cyclophosphamide; Glucocorticoids; Rituximab; Tacrolimus

Criteria

Inclusion Criteria:

• gender is not limited；

• Age 18-75；

• Kidney biopsy pathology suggests primary membranous nephropathy;

• Serological or histological PLA2R positive;

• 24-hour urine protein quantification ≥3.5g/d and serum albumin <30g/L;

• Glomerular filtration rate [eGRF (CKD-EPI formula)] ≥ 45ml/min/1.73m2;

Exclusion Criteria:

• Secondary membranous nephropathy (tumor-related, lupus-related, hepatitis B-related, infection-related, drug-related, etc.);

• Renal biopsy pathology showed severe tubulointerstitial lesions;

• Severe infection, severe cardiac insufficiency, severe hepatic insufficiency, gastrointestinal bleeding, ketoacidosis and other life-threatening complications within one month;

• Glucocorticoids and/or immunosuppressive therapy (cyclophosphamide, MMF, tacrolimus) within 3 months;

• Have a history of kidney transplantation;

• Breastfeeding or pregnant women;

• Patients with mental disorders or unable to cooperate ;