Description: The purpose of this clinical study is to determine the effectiveness of combining rituximab and cyclosporine to treat membranous nephropathy
|Start Date||August 2009|
|Intervention||Ritaximab Infusion and Oral Cyclosporine|
|Phase||This is a Phase 2 trial|
|Estimated Enrollment||30 participants|
|Age||18 years and older|
|Accepts Healthy Volunteers||No|
- Ability and willingness to provide informed consent (adults greater than or equal to 18 years)
- Nephrotic range proteinuria that persists for at least 6 months greater than 3.5 grams/24 hours
- Nephrotic range proteinuria that persists despite angiotensin antagonist therapy for at least 2 months unless intolerant
- Renal biopsy within the past 24 months must reveal typical changes of membranous nephropathy by light and electron microscope
- There is no evidence to suggest secondary forms of membranous nephropathy
- Anyone less than 18 years old
- Immunosuppressive medications or experimental medications of any type during the three month period prior to beginning trial
- Prior exposure to cyclosporine or tacrolimus for more than 6 months and/or evidence of intolerance
- Prior treatment with Rituximab
- Clinically significant medical conditions that could put subjects at risk or could confound the interpretation of the results of this study
- Active acute or chronic infection requiring antimicrobial therapy or serious viral infection
- Live viral vaccines within one month prior to Rituximab
- Pregnant women, nursing mothers or individuals (men or women) not practicing birth control
- Uncontrolled hypertension
- Cancer diagnosis or cancer recurrence within the preceding 5 years, excluding basal cell carcinoma of the skin
- Clinical evidence of cirrhosis or chronic active liver disease
- Diabetes mellitus
Frequently Asked Questions (FAQs)
- Does this study require me to stop taking other medications?
- Participants must stop taking any immunosuppressive medications or experimental medications of any type during the three month period prior to beginning the trial
- Is there a placebo used in this study?
- No, all participants will receive the intervention of a Rituximab infusion and oral Cyclosporine.
- What would I have to do if I participated in this study?
- Participants will go to the NIH in Bethesda, MD for an evaluation and will receive intravenous infusions of Rituximab, which will be give twice (two weeks apart). Participants will take cyclosporine pills twice a day for 6 months. Patients will then undergo two more Rituximab treatments, and will be followed for a total of 24 months from the time the therapy began.
Who can participate?
Adults 18 years and older. Prior diagnosis of MN.
Who do I contact with general questions?
Michelle J Braun: (301-594-7850), firstname.lastname@example.org
Meryl Waldman: (301-451-6990), email@example.com
Where can I learn more?
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Where can I participate?
The following is a list of study sites with contact information for the corresponding principal investigators:
Contact Information by Trial Site
|State||City||Site Name||Contact Information|
|MD||Bethesda||National Institute of Health Clinical Center||Michelle J Braun, CRNP: 301-594-7850, firstname.lastname@example.org; Meryl Waldman, MD: 301-451-6990, email@example.com|
|MD||Bethesda||National Naval Medical Center||Michelle J Braun, CRNP: 301-594-7850, firstname.lastname@example.org; Meryl Waldman, MD: 301-451-6990, email@example.com|