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

May 3, 2021 updated by: Baxalta now part of Shire

A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3052
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research Limited
  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3J4
        • CHUM Hopital Saint-Luc
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7M 0Z9
        • St. Paul´s Hospital
  • Mexico
      • Chihuahua, Mexico, 31238
        • Hospital CIMA Chihuahua
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 3100
        • Mexico Center for Clinical Research S.A de C.V
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Hospital y Clinica OCA SA de CV
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
    • Obregon
      • Sonora, Obregon, Mexico, 85000
        • Clinica San Jose
  • New Zealand
      • Auckland, New Zealand, 1640
        • Middlemore Hospital
      • Auckland, New Zealand, 1071
        • Auckland City Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute Inc.
      • Los Angeles, California, United States, 90022
        • Mohamed A. El-Shahawy
      • Yuba City, California, United States, 95991
        • North Valley Nephrology
    • Colorado
      • Centennial, Colorado, United States, 80112
        • IMMUNOe International Research Centers
      • Denver, Colorado, United States, 80220
        • University of Colorado
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital & Clinic
    • New York
      • Springfield Gardens, New York, United States, 11413
        • Clinical Research Development Associates, LLC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Northeast Clinical Research Center, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Memphis, Tennessee, United States, 38016
        • Ramesh Gupta
      • Memphis, Tennessee, United States, 38119
        • Ramesh Gupta
    • Texas
      • Dallas, Texas, United States, 75390-8523
        • UT Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label Dose-Escalation Arm
Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product
Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Time Frame: Week 21
Week 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma pharmacokinetic parameters
Time Frame: Week 21
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)
Week 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2011

Primary Completion (Actual)

December 31, 2012

Study Completion (Actual)

December 31, 2012

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 1, 2012

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 391001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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