LUNAR: A phase III, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of rituximab in subjects with class III or IV lupus nephritis

May 17, 2006

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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Principal Investigator

Michael D. Lockshin, MD

Co-Investigators

Doruk Erkan, MD

Summary

The purpose of this study is to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF for the treatment of patients with lupus nephritis.  This is a multi-center trial in which patients will be followed for 18 months.

Inclusion/Exclusion Criteria

Patient must have active lupus kidney disease at the time of enrollment.

Contact Information

JoAnn Vega
212.774.2795
vegaj@hss.edu