A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Treatment With Sirukumab (CNTO 136) in Patients With Active Lupus Nephritis.

ABSTRACT:

Objective

To assess the efficacy and safety of sirukumab, an anti-interleukin-6 monoclonal antibody, for the treatment of patients with active lupus nephritis (LN).

Methods

Patients with class III or class IV LN (as determined by renal biopsy within 14 months of randomization) who had persistent proteinuria (>0.5 gm/day) despite receiving immunosuppressive therapy and who were being treated with stable doses of a renin-angiotensin system blocker were randomized (5:1) to receive treatment with sirukumab at a dose of 10 mg/kg intravenously (n = 21) or placebo (n = 4) every 4 weeks through week 24. The primary end point was the percent reduction in proteinuria (measured as the protein-to-creatinine [P:C] ratio in a 12-hour urine collection) from baseline to week 24.

Results<

SUBMITTER: Rovin BH 

PROVIDER: S-EPMC5129491 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature