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

Phase 1TerminatedNCT01541670

Baxalta now part of Shire4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) AntibodyDRUG

Intravenous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

Academic Medical Research Institute Inc.

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality

Time frame: Week 21

Secondary Outcomes

Plasma pharmacokinetic parameters

Maximum concentration (Cmax), minimum concentration (Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL) , mean residence time (MRT), volume of distribution at steady state (Vdss)

Time frame: Week 21

Data from ClinicalTrials.gov

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