US EARLY ACCESS PROGRAM FOR THE TREATMENT OF PATIENTS WITH C3 GLOMERULOPATHY OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS WITH PEGCETACOPLAN
Primary Objective
This EAP allows patients living with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) access to pegcetacoplan in accordance with US EAP regulations. Pegcetacoplan will be available to patients who meet the EAP criteria, until patient discontinuation or until pegcetacoplan is officially registered and approved by the FDA.
Details
Age
Child to Adult
Eligibility
Older than 12, greater than 30kg. Biopsy confirmed diagnosis of C3G or IC-MPGN or biopsy proven recurrence posttransplant. > 1g/day proteinuria. Limited response to treatment regimens.
Locations
Childrens Hospital Colorado
Principal Investigator
Bradley Dixon
Study ID
Protocol Number: 24-1234
Categories
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