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CD40–CD40 ligand (CD40L) interactions play a significant role in the production of autoantibodies and tissue injury in lupus nephritis. We performed an open‐label, multiple‐dose study to evaluate the safety, efficacy, and pharmacokinetics of BG9588, a humanized anti‐CD40L antibody, in patients with proliferative lupus nephritis. The primary outcome measure was 50% reduction in proteinuria without worsening of renal function.

Twenty‐eight patients with active proliferative lupus nephritis were scheduled to receive 20 mg/kg of BG9588 at biweekly intervals for the first 3 doses and at monthly intervals for 4 additional doses. Safety evaluations were performed on all patients. Eighteen patients receiving at least 3 doses were evaluated for efficacy.

The study was terminated prematurely because of thromboembolic events occurring in patients in this and other BG9588 protocols (2 …