Actively Recruiting
Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy
Led by St. Petersburg State Pavlov Medical University · Updated on 2024-05-07
40
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This exploratory study aims to assess the efficacy, safety of the experimental treatment based on a combination of rituximab (RTX), intravenous (IV) cyclophosphamide (CYC), and corticosteroids (S) administrated at lower cumulative doses (RCP) for the induction of early remission in subjects with anti-PLA2R antibody-positive primary membranous nephropathy (PMN) having nephrotic syndrome (NS).
CONDITIONS
Official Title
Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Biopsy-confirmed primary membranous nephropathy with exclusion of significant other diseases
- Signed informed consent
- Elevated serum anti-PLA2R antibody levels greater than 20 RU/ml
- No contraindications to immunosuppressive therapy
- Presence of nephrotic syndrome with either persistent symptoms over 6 months despite treatment, complications related to nephrotic syndrome, recurrence after remission, or treatment failure of another immunosuppressive regimen
You will not qualify if you...
- Secondary causes of membranous nephropathy such as hepatitis B, lupus, medications, or malignancies
- Diagnosis of type 1 or 2 diabetes mellitus
- Current or recent acute or chronic infection, including recent hospitalization or antimicrobial therapy
- Women who are pregnant, nursing, or unwilling to use approved contraception
- History of mental illness with recent suicidal behavior or ideation
- History of immunodeficiency or organ transplantation
- Vaccination with live vaccines within the past 30 days
- Current or recent drug or alcohol abuse or dependence
- Inability to comply with study procedures
- Laboratory abnormalities including low hemoglobin, platelets, neutrophils, or elevated liver enzymes
- Investigator judgment deeming patient ineligible
- Estimated glomerular filtration rate below 30 ml/min/1.73m2 at baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia, 197022
Actively Recruiting
Research Team
V
Vladimir Dobronravov, Professor
CONTACT
Z
Zinaida Kochoyan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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