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Immunosuppressant
Rituximab + Cyclosporine for Glomerulonephritis
Bethesda, MD
Phase 2
Recruiting
Led By Meryl A Waldman, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Rapid decline in renal function within less than 6 months with complications of nephrotic syndrome or evidence of decline in glomerular filtration rate or proteinuria >8 grams/day
Renal biopsy within the past 24 months revealing typical changes of membranous nephropathy by light and electron microscopy or a positive anti-PLA2R antibody test in the serum
Must not have
Diabetes mellitus
Prior exposure to cyclosporine or tacrolimus for more than 6 months and/or evidence of intolerance or toxicity associated with cyclosporine treatment of any duration including irreversible azotemia, liver dysfunction or hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and effectiveness of combining two drugs to treat membranous nephropathy, a kidney disease associated with damage to the walls of the glomeruli. The first drug, rituximab, is an immunosuppressant that attempts to reduce the activity of the immune system. The second drug, cyclosporine, is a blood pressure lowering medication. The trial will last up to 2 years, and participants will have frequent blood and urine tests.
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Who is the study for?
Adults over 18 with membranous nephropathy confirmed by kidney biopsy within the last 24 months, and persistent proteinuria despite treatment. Participants must be able to take oral medication, adhere to a specific regimen, and use effective contraception if of reproductive potential. Exclusions include HIV/HCV positivity, recent cancer (except skin), severe liver disease, certain blood disorders, diabetes, low kidney function, recent immunosuppressants or rituximab use.Check my eligibility
What is being tested?
The trial is testing the combination of Rituximab infusions and oral Cyclosporine in treating membranous nephropathy. It involves an initial evaluation followed by a run-in period without other immunosuppressants. Treatment includes four doses of Rituximab and six months of Cyclosporine therapy with follow-up visits for monitoring through frequent blood and urine tests.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune suppression such as increased risk of infections; possible organ inflammation; infusion-related reactions from Rituximab; kidney or liver impairment due to Cyclosporine; as well as general symptoms like fatigue or digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function has worsened quickly in less than 6 months, with severe symptoms or very high protein levels in my urine.
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I have a confirmed diagnosis of membranous nephropathy either by kidney biopsy or a positive anti-PLA2R test.
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I can take pills and follow a medication schedule.
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My kidney condition is not caused by another disease.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes.
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I have used cyclosporine or tacrolimus for over 6 months or had a bad reaction to them.
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My kidney function is low, with a GFR under 40, while on specific blood pressure meds.
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I haven't needed antibiotics for infections or had serious viral infections in the last 2 years.
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My blood tests show low neutrophils, platelets, or CD4 T cell count.
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I was diagnosed with or had a recurrence of cancer, other than skin cancer, in the last 5 years.
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I have severe liver disease that affects medication breakdown.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of complete and partial remissions (CR and PR)
Safety
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination of Rituximab plus cyclosporineExperimental Treatment2 Interventions
2 infusions (each 1000 mg) separated by 2 weeks; repeated after 6 months. Daily therapy for 6 months (3-5 mg/kg), then tapered and discontinued.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab Infusion
2013
Completed Phase 4
~20
Find a Location
Closest Location:National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,506 Previous Clinical Trials
4,365,683 Total Patients Enrolled
Meryl A Waldman, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 Previous Clinical Trials
2,456 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.I am 18 years old or older.I have used cyclosporine or tacrolimus for over 6 months or had a bad reaction to them.My kidney function is low, with a GFR under 40, while on specific blood pressure meds.I haven't needed antibiotics for infections or had serious viral infections in the last 2 years.I have high levels of protein in my urine despite taking angiotensin antagonist for 2 months or I cannot tolerate it.My blood pressure has been 140/90 or lower on most checks while on medication for 1-2 months.I am willing and able to follow the study rules and attend all required visits.I have not received any live vaccines within a month before starting Rituximab.My blood tests show low neutrophils, platelets, or CD4 T cell count.I have had high levels of protein in my urine for over 6 months since being diagnosed with membranous nephropathy.I have been using effective birth control for at least a month and agree to continue for 12 months after my last treatment.My kidney function has worsened quickly in less than 6 months, with severe symptoms or very high protein levels in my urine.I haven't taken any immunosuppressive or experimental drugs in the last 3 months.I have a confirmed diagnosis of membranous nephropathy either by kidney biopsy or a positive anti-PLA2R test.I was diagnosed with or had a recurrence of cancer, other than skin cancer, in the last 5 years.I can take pills and follow a medication schedule.You have tested positive for HIV or HCV.My kidney condition is not caused by another disease.I have used Rituximab in the last 12 months.I have severe liver disease that affects medication breakdown.I am a man who can father children and will use contraception.
Research Study Groups:
This trial has the following groups:- Group 1: Combination of Rituximab plus cyclosporine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.