search
Back to results

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

Primary Purpose

Systemic Lupus Erythematosus

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Sponsored by
Baxalta now part of Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Research Institute Inc.
  • Mohamed A. El-Shahawy
  • North Valley Nephrology
  • IMMUNOe International Research Centers
  • University of Colorado
  • Tulane University Hospital & Clinic
  • Clinical Research Development Associates, LLC
  • Northeast Clinical Research Center, LLC
  • Medical University of South Carolina (MUSC)
  • Ramesh Gupta
  • Ramesh Gupta
  • UT Southwestern Medical Center at Dallas
  • Austin Health
  • The Alfred Hospital
  • Linear Clinical Research Limited
  • CHUM Hôpital Saint-Luc
  • St. Paul´s Hospital
  • Mexico Center for Clinical Research S.A de C.V
  • Hospital y Clinica OCA SA de CV
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Clinica San Jose
  • Hospital CIMA Chihuahua
  • Auckland City Hospital
  • Middlemore Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label Dose-Escalation Arm

Arm Description

Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
February 20, 2012
Last Updated
May 3, 2021
Sponsor
Baxalta now part of Shire
search

1. Study Identification

Unique Protocol Identification Number
NCT01541670
Brief Title
Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis
Official Title
A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Study Start Date
November 28, 2011 (Actual)
Primary Completion Date
December 31, 2012 (Actual)
Study Completion Date
December 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label Dose-Escalation Arm
Arm Type
Experimental
Arm Description
Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product
Intervention Type
Drug
Intervention Name(s)
Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intervention Description
Intravenous injection
Primary Outcome Measure Information:
Title
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Time Frame
Week 21
Secondary Outcome Measure Information:
Title
Plasma pharmacokinetic parameters
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Academic Medical Research Institute Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Mohamed A. El-Shahawy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
North Valley Nephrology
City
Yuba City
State/Province
California
ZIP/Postal Code
95991
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Tulane University Hospital & Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Clinical Research Development Associates, LLC
City
Springfield Gardens
State/Province
New York
ZIP/Postal Code
11413
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Ramesh Gupta
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38016
Country
United States
Facility Name
Ramesh Gupta
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8523
Country
United States
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Linear Clinical Research Limited
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
CHUM Hôpital Saint-Luc
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
St. Paul´s Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 0Z9
Country
Canada
Facility Name
Mexico Center for Clinical Research S.A de C.V
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
3100
Country
Mexico
Facility Name
Hospital y Clinica OCA SA de CV
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Clinica San Jose
City
Sonora
State/Province
Obregon
ZIP/Postal Code
85000
Country
Mexico
Facility Name
Hospital CIMA Chihuahua
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1071
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
1640
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs