Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
This open label, non-blinded, proof of concept efficacy and safety study of eculizumab in
patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult patients
with these diseases who have > 1 gram of proteinuria or a decreased glomerular filtration
rate (GFR), both predictors of a poor long-term outcome in many glomerular diseases. The
patients will be treated with eculizumab for one year.
The goals will be to determine whether treatment leads to an improvement in kidney function,
defined by remissions of proteinuria and improvements in estimated GFR (measured by serum
creatinine), and to improvement in histologic parameters, including percentage of
non-affected glomeruli, interstitial fibrosis, intensity of C3 staining of
immunofluorescence, and amount of electron dense deposits by electron microscopy.