Research Study Summary
Velcade Therapy For Severe IgA Nephropathy
The Rogosin Institute is conducting a clinical research study to assess the safety and efficacy of Velcade® to treat severe IgA nephropathy. Velcade® is FDA-approved for the treatment of multiple myeloma, not for IgA nephropathy, but it may act on non-cancerous normal plasma cells that produce abnormal antibody proteins. IgA nephropathy is a form of kidney disease where abnormal immunoglobulins type A (IgA), a natural antibody produced in plasma cells to protect infections, accumulate in the kidney and cause irritation and inflammation. There is currently no effective treatment for this condition.
Subjects who are found eligible for the study after the screening visit will be seen at the Weill Cornell Medical College CTSC (Clinical and Translational Science Center) outpatient unit to receive 4 doses (1 cycle) of the study drug through a vein and at The Rogosin Institute Outpatient Clinic for some follow-up visits for approximately forty days. If there is no response as measured by blood and urine analysis after the first cycle, a second cycle will be initiated approximately a month later. Follow-up visits, involving physical examinations, blood and urine collections, will take place monthly thereafter for a total participation in the study of one year. Each visit should take approximately 1 hour. A stipend will be given for each study visit completed. Throughout the study, the principal investigator and study doctors will monitor all the medications taken, regardless of their indication.
You may or may not get direct benefits from this study. The presence of protein in your urine might not get better, or may even get worse during the study. However, new information may be collected that may benefit patients with IgA nephropathy in the future.
To qualify for the study you must:
- Be over 18 years of age,
- Have a diagnosis of IgA nephropathy proven by biopsy,
- Have creatinine clearance (a measure of your kidney function) over or equal to 30 cc/min/1.73 m2,
- Have protein in the urine (over 1 gram per day),
- Be on specific high blood pressure medication (known as ACE inhibitors, ARB or renin inhibitors) for at least a month before entering the study,
- Have normal liver function.
To qualify for the study you must NOT:
- Have HIV or hepatitis B or C.
- Have cancer.
- Be pregnant, or plan on becoming pregnant, or be breastfeeding.
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