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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00275613 |
Membranoproliferative glonerulonephritis (MPGN) is a relatively-rare, immune-mediated kidney disease. All current therapies are inadequate and MPGN frequently leads to kidney failure. This study is a 10 patient trial of the monoclonal antibody rituximab for adult patients with MPGN. Study patients will receive 2 doses of rituximab intravenously on days 1 and 15 and will then be followed for 1 year.
Condition | Intervention | Phase |
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Membranoproliferative Glomerulnephritis |
Drug: Rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Study of Rituximab for Membranoproliferative Glomerulonephritis |
Estimated Enrollment: | 10 |
Study Start Date: | November 2005 |
Membranoproliferative glomerulonephritis (MPGN) is a relatively-rare, immune-mediated glomerular disease. There is no accepted therapy and all current therapies are inadequate. Current therapeutic options include immunosuppression with corticosteroids alone or in combination with alkylating agents, antiplatelet therapy with aspirin and/or dipyridamole and/or warfarin, and angiotensin converting enzyme inhibitors and/or angiotensin receptor blockers. As with other glomerular diseases the amount of protein in the urine correlates well with the long-term prognosis. Thus, this parameter has been used in previous studies, and will be used in this study, as the primary indicator of therapeutic efficacy. We propose a pilot study to test the hypothesis that selective B lymphocyte depletion will result in disappearance of pathogenic antibodies and induce remission of proteinuria in patients with idiopathic membranoproliferative glomerulonephritis. Our population will be 10 adults with MPGN involving either the native kidneys or a renal transplant. We will enroll patients with a GFR ≥ 25 ml/min, as estimated by creatinine clearance, and with a 24 hour urinary ratio of protein to creatinine (Upro/Ucreat) ≥ 2, while receiving an ACEI or ARB. Patients will receive Rituximab 1g on Day 1 and 15.
Patients will be followed for 1 year following completion of treatment. The primary outcome will be the change in urinary protein excretion at 6 months. Secondary outcomes will include changes in the glomerular filtration rate (GFR), changes in urinary protein excretion at 3, 9 and 12 months, the rate of change in urinary protein excretion, serum albumin concentration, serum cholesterol, the number of complete and partial remissions, time to remission, and the number of relapses.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 976-05 |
Study First Received: | January 10, 2006 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00275613 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Glomerulonephritis Immunologic Factors Urologic Diseases Rituximab |
Nephritis Glomerulonephritis, Membranoproliferative Kidney Diseases Antirheumatic Agents |
Glomerulonephritis Immune System Diseases Immunologic Factors Rituximab Antineoplastic Agents Physiological Effects of Drugs Glomerulonephritis, Membranoproliferative |
Pharmacologic Actions Urologic Diseases Nephritis Therapeutic Uses Kidney Diseases Antirheumatic Agents |