Efficacy of Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy

Conditions

• Idiopathic Membranous Nephropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Rituximab combined with or without cyclosporine
• Modified Ponticelli regimen — DRUG
  Corticosteroid and cyclophosphamide

Study Details

Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults. Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.

Key Dates

Start date

Aug 4, 2022

Status verified

Mar 2023

Primary completion

Dec 4, 2023

Completion

Dec 4, 2023

Study Design

Enrollment

2 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  Patients received rituximab 100 and 500 mg of intravenous medication on days 1 and 2, respectively. If proteinuria was reduced from baseline by no more than 25% at 3 months, cyclosporine was administered. In addition, CD19+ B-cell count was monitored every 3 months, and another rituximab 100 and 500 mg will be administered if CD19+ B-cell count \>5 cells/mL.
• Active Comparator: Modified Ponticelli regimen
  Patients received corticosteroids at months 1, 3, and 5 (methylprednisolone 0.5 g at days 1, 2, and 3, then prednisone 0.5 mg/kg/d from day-4 to day-30). At months 2, 4, and 6, patients received cyclophosphamide adjusted for age and renal function (1.0-2.0 mg/kg/day for 30 days, maximum dose 100 mg/d).

Primary Outcome Measure

remission of nehprotic syndrome [ Time Frame: 12 months ]