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

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

Efficacy and Safety of Low Dose Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782933
• Other study ID #: 2022-P2-250-01
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: December 4, 2023

Study information

• Verified date: March 2023
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 4, 2023
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Drug:
• Rituximab
Rituximab combined with or without cyclosporine
• Modified Ponticelli regimen
Corticosteroid and cyclophosphamide

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission of nehprotic syndrome	The primary clinical outcome was a composite outcome with complete remission or partial remission of nehprotic syndrome at 12 months. Complete remission was defined as a reduction of proteinuria to = 0.3 g/24 h plus stable kidney function (eGFR =45 mL/min per 1.73 m2). Partial remission was defined as a reduction of proteinuria of = 50% from baseline, and <3.5 g/24 h plus stable renal function (eGFR =45 mL/min per 1.73 m2).	12 months
Secondary	Complete remission of nehprotic syndrome	Complete remission was defined as a reduction of proteinuria to = 0.3 g/24 h plus stable kidney function (eGFR =45 mL/min per 1.73 m2).	12 months
Secondary	adverse events	The prevalence of adverse events including infections, hyperglycemia etc will be recored.	12 months