UNC Kidney Center Current Clinical Trials

Current clinical trials:

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A Multicenter, Randomized, Prospective, Open-Label Trial of Rituximab in the Treatment of Progressive IgA Nephropathy

Sponsored by: Genentech, Inc.

Principal Investigator: Patrick Nachman, MD

The purpose of this study is to compare the ability of Rituximab to standard therapy (tight blood pressure control and fish oil) in lowering protein in the urine in patients with IgA nephropathy, and to examine the side effects occurring with Rituximab.  Approximately 50 patients (5 for UNC Kidney Center) will be randomized to Rituximab in addition to standard therapy vs. standard therapy alone in an open-label multicenter controlled trial.  Patients randomized to the Rituximab group will receive a total of 4 doses on days #1; 15; 168 and 182.  Standard therapy will consist of combination ACE inhibitors and ARBs to achieve a BP goal of 125/75 (MAP 90 mm Hg) and Omega-3 Fatty Acid Fish Oil Supplements, 3.6 gm EPA/day.  Patients will be followed for a total of 12 months.

Inclusion Criteria:

Note: All eligible patients will have undergone a renal biopsy compatible with a diagnosis of IgA nephropathy within 12 months of study entry. The diagnostic criteria for IgA nephropathy are as follows:

Exclusion Criteria:

For more information, please contact:

Anne Froment
(919) 966-2561 ext 247
anne_froment@med.unc.edu

 

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