Diagnosis and natural course of membranous nephropathy.
Richard J Glassock
https://pubmed.ncbi.nlm.nih.gov/12923720Actively Recruiting
Phase 2
Age: 18Years - 90Years
All Genders
ID00977977
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy for Adults with Persistent Proteinuria
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-06-08
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment of rituximab and cyclosporine for adults with idiopathic membranous nephropathy, a kidney condition that damages the blood vessels responsible for filtering waste. This damage leads to protein leakage into urine, low blood protein levels, high cholesterol, and leg swelling. While some patients improve without treatment, persistent symptoms can lead to kidney failure, heart and blood vessel disease, and blood clots. The study aims to determine the safety and effectiveness of this combined immunosuppressive approach compared to existing treatments. Participants will undergo a screening and a run-in period lasting up to two months, during which blood pressure medications are given without other immunosuppressants. The active treatment phase involves six months of twice-daily oral cyclosporine and four intravenous rituximab infusions—two doses spaced two weeks apart at the start, and two more after six months depending on blood test results. After six months, cyclosporine is gradually reduced and stopped. Throughout the study, frequent blood and urine tests will monitor treatment effects and potential side effects. Participants will visit the clinical center for baseline assessments and follow-up evaluations at intervals ranging from one to six months. Researchers will measure safety outcomes and track the number of complete or partial remissions of proteinuria at six, twelve, eighteen, and twenty-four months. Secondary measures include time to remission or relapse and changes in protein levels in urine. The total study duration allows long-term monitoring to assess both effectiveness and safety of the combined therapy.
CONDITIONS
Brief Title
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Willingness to follow all study procedures and be available for the study duration
- Male or female aged 18 to 90 years
- Persistent nephrotic range proteinuria greater than 3.5 grams per 24 hours for at least 6 months
- Proteinuria persisting despite at least 2 months of angiotensin antagonist therapy unless intolerant
- Kidney biopsy within past 24 months showing membranous nephropathy or positive anti-PLA2R antibody test
- Blood pressure controlled at or below 140/90 mmHg on medication for at least 1-2 months
- No evidence of secondary membranous nephropathy
- Ability to take oral medications and willingness to follow cyclosporine regimen
- For females of reproductive potential, use of effective contraception before and during the study and for 12 months after last rituximab dose
- For males of reproductive potential, use of condoms or other effective contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Estimated glomerular filtration rate below 40 ml/min/1.73 m2 within 2 months before enrollment
- Use of immunosuppressive or experimental medications within 3 months before starting study drugs
- Previous cyclosporine or tacrolimus use over 6 months or intolerance to cyclosporine
- Rituximab use within the past 12 months
- Serious medical conditions such as severe heart failure or uncontrolled coronary artery disease
- Positive tests for HIV or hepatitis C
- Active infections requiring treatment or serious viral infections in past 24 months
- Live viral vaccine within one month prior to rituximab
- Pregnancy or breastfeeding
- Cancer diagnosis or recurrence within past 5 years, except certain skin cancers
- Severe liver disease impairing cyclosporine metabolism
- Low blood cell counts or low CD4 T cell count
- Diabetes mellitus which may worsen proteinuria and affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months with cyclosporine daily therapy, rituximab infusions repeated after 6 months
Participants receive a combination of rituximab infusions and daily oral cyclosporine therapy to treat idiopathic membranous nephropathy.
2 rituximab infusions separated by 2 weeks; daily cyclosporine; follow-up visits during treatment
Follow-up
Duration - Up to 18 months after treatment start with safety assessed to 24 months
Participants are monitored after treatment to assess safety, remission, relapse, and proteinuria changes.
Periodic visits for assessments up to 24 months
Trial Site Locations
Total: 2 locations
1
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Actively Recruiting
2
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
M
Meryl A Waldman, M.D.
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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Published Research Related To This Trial
Management of membranous nephropathy: when and what for treatment.
Daniel Cattran
https://pubmed.ncbi.nlm.nih.gov/15800117Molecular mechanisms of glomerular injury in rat experimental membranous nephropathy (Heymann nephritis).
D Kerjaschki, T J Neale
https://pubmed.ncbi.nlm.nih.gov/8989729Prediagnostic Appearance of Thrombospondin Type-1 Domain 7A Autoantibodies in Membranous Nephropathy.
Peter D Burbelo, Stephen W Olson, Jason M Keller...
https://pubmed.ncbi.nlm.nih.gov/36821613