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Sponsors and Collaborators: |
Southeast Renal Research Institute University of Pennsylvania Ohio State University Stanford University Mayo Clinic University of North Carolina |
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Information provided by: | Southeast Renal Research Institute |
ClinicalTrials.gov Identifier: | NCT00498368 |
Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis and other forms immune complex glomerulonephritis has led to its investigation in the treatment of IgA nephropathy. Because IgA class antibodies have comparatively short half-lives and that deposition of polymeric forms of IgA contributes to glomerular injury, we speculate that the reduction of circulating IgA may reduce proteinuria and injury in patients with IgA nephropathy. Moreover, the absence of prospective trials in the treatment of IgA disease and the lack of consensus for long-term treatment, the superior side-effect profile of this form of therapy may lead to significant advances in the treatment of this prevalent from of glomerulonephritis.
Condition | Intervention | Phase |
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IGA Nephropathy |
Drug: Intravenous Rituximab Therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Prospective, Open-Label Trial of Rituximab in the Treatment of Progressive IgA Nephropathy |
Estimated Enrollment: | 54 |
Study Start Date: | August 2007 |
Ages Eligible for Study: | 5 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Renal Histology-Entry Criteria:
Note: All eligible patients will have undergone a renal biopsy compatible with a diagnosis of IgA nephropathy within 3 months of study entry. The diagnostic criteria for IgA nephropathy are as follows:
Clinical Criteria:
(For Stanford University site only: Stanford has extensive experience with pediatric, as young as one year of age, use of Rituximab in acute renal transplant rejection therefore request that the patients must be between the ages of 5 and 70.)
Exclusion Criteria:
General Safety & Laboratory Exclusion Criteria
Contact: James A Tumlin, MD | 704-927-1757 | jtumlin@emory.edu |
Contact: Kelly Feilds, BA | 704-927-1757 | kelly.fields@SoutheastRenal.com |
United States, California | |
Stanford University | |
San Francisco, California, United States, 94304 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, North Carolina | |
Southeast Renal Associates | |
Charlotte, North Carolina, United States, 28208 | |
University of North Carolina Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7005 | |
United States, Ohio | |
The University of Ohio | |
Columbus, Ohio, United States, 43210-1063 | |
United States, Pennsylvania | |
Temple University | |
Philadelphia, Pennsylvania, United States, 19140 |
Principal Investigator: | James A Tumlin, MD | Southeast Renal Research Institute |
Study ID Numbers: | GTH-IgA-12795 |
Study First Received: | July 9, 2007 |
Last Updated: | July 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00498368 |
Health Authority: | United States: Food and Drug Administration |
Estimated GFR Protinuria Renal Fibrosis |
Glomerulonephritis Autoimmune Diseases Urologic Diseases Rituximab Fibrosis |
Nephritis Berger disease Glomerulonephritis, IGA Kidney Diseases |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |