Effect of Tacrolimus vs Intravenous Cyclophosphamide on Complete or Partial Response in Patients With Lupus Nephritis: A Randomized Clinical Trial.

ABSTRACT:

Importance

Lupus nephritis (LN) is typically treated with intravenous cyclophosphamide (IVCY), which is associated with serious adverse effects. Tacrolimus may be an alternative for initial treatment of LN; however, large-scale, randomized clinical studies of tacrolimus are lacking.

Objective

To assess efficacy and safety of tacrolimus vs IVCY as an initial therapy for LN in China.

Design, setting, and participants

This randomized (1:1), open-label, parallel-controlled, phase 3, noninferiority clinical trial recruited patients aged 18 to 60 years with systemic lupus erythematosus and LN class III, IV, V, III+V, or IV+V primarily from outpatient settings at 35 centers in China. Inclusion criteria included body mass index of 18.5 or greater to less than 27, 24-hour urin

SUBMITTER: Zheng Z 

PROVIDER: S-EPMC8969066 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature