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Rituximab + Cyclosporine for Glomerulonephritis
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Combination of Rituximab plus cyclosporine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many people are signed up for this research project?
"That is correct, the online clinicaltrials.gov database has this information regarding the study's status. The trial was established on December 22nd 2010 and updated on November 16th 2022. They are seeking 30 individuals total from 3 locations."
Could you elaborate on the age bracket this research is applicable to?
"Eligible patients for this trial must be over 18 years old but not yet reached their 100th birthday."
Is there a Rituximab Infusion protocol patients can follow to reduce side effects?
"While there is some evidence of Rituximab Infusion being safe, it is only from Phase 2 trials. This means that there is no data supporting its efficacy."
Are there any available positions for volunteers in this experimental procedure?
"Yes, this research study is still looking for volunteers and has been since 2010. The listing on clinicaltrials.gov was updated as recently as November 16th, 2020."
Would I be able to help out with this medical study?
"This study is admitting 30 participants, within the ages of 18 and 100 who currently have heymann nephritis. It is important that patients also meet the following criteria: Stated willingness to comply with all study procedures and availability for the duration of the study, Male or female, >= 18 years of age, Nephrotic range proteinuria that persists for at least 6 months post diagnosis of membranous nephropathy greater than 3.5 grams /24 hours (based on 24-hour urine collection), a. If the subject's renal function rapidly declines in less than 6 months could proceed with immunosuppression therapy"
What are the conditions that Rituximab Infusion is commonly used to alleviate?
"Rituximab Infusion is the standard course of treatment for post-kidney transplant patients. Additionally, this immunotherapy can help ameliorate dry eye syndromes and certain types of glomerulosclerosis that have not responded to other forms of therapy."
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