Clinical Trials

1 studies in IgA Nephropathy

1. Rituximab in Progressive IgA Nephropathy Rochester, MN View Summary
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   Rituximab in Progressive IgA Nephropathy

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease. Rituximab doses for pediatric patients will be 375mg/m² of rituximab on Days 1 and Day 15 and Days 168 and 182. 2.0 OBJECTIVES 2.1 Primary Efficacy Endpoints: Percentage of patients in each group achieving complete or partial response as defined below: Complete Response: At 12 months 1. < 300 mg proteinuria/24 hours Pediatric Criteria: First morning void urine protein: creatinine ratio <0.3 2. No greater than a 10% reduction in baseline estimated GFR as determined by MDRD (4 point) formula Pediatric criteria: No greater than a 10% reduction in baseline estimated GFR as determined by Schwartz formula Partial Response: At 12 months 1) > 50% reduction in 24 hour proteinuria 2) No greater than a 25% reduction in baseline estimated GFR as determined by MDRD formula Pediatric criteria: No greater than a 25% reduction in baseline estimated GFR as determined by Schwartz formula No Response: At 12 months 1. A 50% reduction, unchanged or increasing proteinuria over baseline levels will be considered no response 2. A greater than a 30% reduction in baseline estimated GFR as determined by MDRD formula Pediatric criteria: A greater than a 25% reduction in baseline estimated GFR as determined by Schwartz formula 2.2 Primary Safety Endpoints: - Incidence of Infusion Related Reactions: Defined as the development of hypotension, generalized pruritus, chills/rigors, angioedema and/or bronchospasm. - Pulmonary Complications: Defined as a hypoxia, pulmonary infiltrates and/or acute respiratory failure - Incidence of Major Infections: Defined as the development of pneumonia, complicated UTI/Pyelonephritis, Sepsis, and Meningitis. - Development of Progressive Multifocal Leukoencephalopathy (PML) 2.3 Secondary Exploratory Efficacy Endpoints: A) For patients in Groups 1 & 2 consenting to a repeat kidney biopsy at 12 months, a secondary endpoint will include the percentage of patients in experiencing a 25% increase in cortical fibrosis. The response rate will be semi-quantified by the change in cortical fibrosis as measured by changes in Sirius Red staining of interstitial collagen. A patient will be considered a complete or partial response or no response according to the following criteria: Complete: Less than 10% rise in cortical fibrosis as measured by Sirius Red staining and digital image analysis Partial: Rising cortical fibrosis > 10% but less than 25% No Response: Greater than 25% rise in cortical fibrosis over baseline levels-(if patient consents to repeat kidney biopsy)

   NCT ID:

   NCT00498368

   IRB Number:

   07-001944

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   Who can I contact for additional information about this study?

   Rochester: Fernando C. Fervenza, M.D., Ph.D. 507-266-7961
                       Shirley A Jennison 507-255-0231