A Phase 2 interventional study of Eculizumab in Membranoproliferative Glomerulonephritis, sponsored by Mario Negri Institute for Pharmacological Research. Completed at 13 sites in Italy. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Mario Negri Institute for Pharmacological Research · Phase 2, Interventional, and Treatment
Membranoproliferative glomerulonephritis (MPGN) is the third or fourth leading cause of end stage renal disease among the primary glomerulonephritis. Hyperactivation of the alternative complement pathway and familial forms for all types of MPGN have been reported suggesting that genetic abnormalities may play a predisposing role to the disease. In recent case reports Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the membrane attack complex ,is a safe and effective therapy.
149 studies on the registry are indexed under Glomerulonephritis; 38 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 112 interventional studies indexed under Glomerulonephritis.
Browse Glomerulonephritis studies →Mario Negri Institute for Pharmacological Research is the lead sponsor of 159 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient Body weight ≥40 kg: initial phase 900 mg weekly x 4 and maintenance phase 1200 mg at week 5; then 1200 mg every 2 weeks Patient Body weight 30 - \<40 kg : initial phase 600 mg weekly x 2 and maintenance phase 900 mg at week 3; then 900 mg every 2 weeks
Drug: Eculizumab
Also known as: Soliris
24hours proteinuria
Time frame: Changes from baseline at week 1,12,24,36,48 and 72.
Terminal complement complex (sC5b-9) levels
Time frame: Changes from baseline at 1,2, 3, 4,12,24,36,48,52,56,60 and 72 week.
Glomerular filtration rate (GFR) measured by iohexol plasma clearance and estimated.
Time frame: Changes from Baseline at 1,24, 48 and 72 week.
Time to disease progression.
Time frame: Up 72 week.
Number of participants with Adverse Events as a measure of safety.
Time frame: Participants will be followed for the duration of the study, an expected average of 72 weeks
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Mario Negri Institute for Pharmacological Research