Clinical Trial: Eculizumab in Primary MPGN
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: EVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS: A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTEN
Brief Summary: 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.
Detailed Summary:
Sponsor: Mario Negri Institute for Pharmacological Research
Current Primary Outcome: 24hours proteinuria [ Time Frame: Changes from baseline at week 1,12,24,36,48 and 72. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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. ]
Original Secondary Outcome: Same as current
Information By: Mario Negri Institute for Pharmacological Research
Dates:
Date Received: March 17, 2014
Date Started: March 2014
Date Completion: June 2017
Last Updated: April 12, 2016
Last Verified: April 2016
