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

NCT ID: NCT05782933

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2023-12-04

Brief Summary

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.

Conditions

Idiopathic Membranous Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Rituximab combined with or without cyclosporine

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).

Group Type: ACTIVE_COMPARATOR

Modified Ponticelli regimen

Intervention Type: DRUG

Corticosteroid and cyclophosphamide

Interventions

Rituximab

Rituximab combined with or without cyclosporine

Intervention Type: DRUG

Modified Ponticelli regimen

Corticosteroid and cyclophosphamide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. age 18-70 years; serum albumin level <30 g/L;

2. estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;

3. patients with a moderate risk of IMN and decline <50% in proteinuria despite blockade of the renin-angiotensin system 3 months before randomization;

4. patients at high risk or very high risk of IMN.

Exclusion Criteria

1. secondary causes of MN;

2. being pregnant or breastfeeding;

3. uncontrollable active infectious disease;

4. immunosuppressive treatment in the preceding 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wenhu Liu

Professor Wenhu Liu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zongli Diao, M.D.

Role: primary

diaozl@ccmu.edu.dn

+861063138679

Other Identifiers

2022-P2-250-01

Identifier Type: -

Identifier Source: org_study_id