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New treatment option for Nephrotic Syndrome
Official title Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
ClinicalTrials.gov ID: NCT00977977
What this study is testing
What is Rituximab Infusion?
Rituximab Infusion is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for nephrotic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Membranous nephropathy is associated with damage to the walls of the glomeruli, the small blood vessels in the kidneys that filter waste products from the blood. This damage causes leakage of blood proteins into the urine and is associated with low blood protein levels, high blood cholesterol values, and swelling of the legs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of 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...
- Nephrotic range proteinuria (\>3.5 g/24 hours) that persists despite angiotensin antagonist therapy (ACE inhibitor or ARB) for at least 2 months...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Estimated GFR\<40 ml/min/1.73 m\^2 from the preceding 2 months prior to enrollment while on ACEI/ARB therapy.
- Immunosuppressive medications or experimental medications of any type during the three-month period prior to initiating Rituximab and cyclosporine.
- Prior exposure to cyclosporine or tacrolimus for more than 6 months and/or evidence of intolerance or toxicity associated with cyclosporine treatment...
- Rituximab use within the previous 12 months.
- Clinically significant medical conditions (i.e., severe heart failure NYHA class IV, uncontrolled coronary artery disease/unstable angina), which in...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of 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...
- Nephrotic range proteinuria (\>3.5 g/24 hours) that persists despite angiotensin antagonist therapy (ACE inhibitor or ARB) for at least 2 months unless intolerant. a. The rationale is that blockade of the renin...
- Renal biopsy within the past 24 months must reveal typical changes of membranous nephropathy by light and electron microscopy or a positive anti-PLA2R antibody test in the serum. There has been a change in the...
- Blood pressure \ 75% of measurement while on anti-hypertensive treatment for at least 1-2 months.
- There is no evidence to suggest secondary forms of membranous nephropathy.
- Ability to take oral medication and be willing to adhere to the cyclosporine regimen
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for 12 months after the last...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Estimated GFR\<40 ml/min/1.73 m\^2 from the preceding 2 months prior to enrollment while on ACEI/ARB therapy.
- Immunosuppressive medications or experimental medications of any type during the three-month period prior to initiating Rituximab and cyclosporine.
- 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...
- Rituximab use within the previous 12 months.
- Clinically significant medical conditions (i.e., severe heart failure NYHA class IV, uncontrolled coronary artery disease/unstable angina), which in the opinion of the investigator, could increase the subject s risk of...
- Positive HIV serology
- Positive HCV serology
- Active acute or chronic infection requiring antimicrobial therapy or serious viral infection cytomegalovirus, herpes simplex, varicella zoster virus (chicken pox or shingles), Parvovirus B19 (can be based on previous...
- Live viral vaccines within one month prior to Rituximab.
- Pregnancy or lactation
- Cancer diagnosis or cancer recurrence within the preceding 5 years, excluding basal cell carcinoma of the skin. The rationale is that immunosuppression may accelerate cancer progression.
- Clinical evidence of cirrhosis or chronic active liver disease sufficiently severe to impair cyclosporine metabolism; this would include a prolonged prothrombin time.
- Cytopenia (neutrophils \<1500/mm\^3 and/or thrombocytopenia \<75,000) and/or CD4 T cell count \<200/mm\^3). The rationale is that Rituximab therapy may be followed by cytopenia with the granulocyte lineage being at...
- Diabetes mellitus. The rationale is that diabetes may lead to worsening of proteinuria that would not respond to immunosuppression and would confound the results.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.