Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis

• Status: Terminated
• Trial end date: 2012-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxalta now part of Shire; Baxalta US Inc.
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• Signed and dated written informed consent obtained from the subject

• Males and females of age 18 years and older at the time of screening

• Established diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria

• Documented renal biopsy evidence of proliferative glomerulonephritis prior to screening

• Urine protein-to-creatinine ratio > 0.5 (mg/mg)

Exclusion Criteria:

• Any significant health problem other than lupus or lupus nephritis