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| Sponsors and Collaborators: |
Medical University of Vienna Hospital Hietzing Medical University of Graz Charite University, Berlin, Germany University of Erlangen-Nürnberg Heinrich-Heine University, Duesseldorf University of Schleswig-Holstein University Medical Centre Groningen Leiden University Medical Center Radboud University |
|---|---|
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00368264 |
Purpose
Background:
Standard therapy is ill-defined for patients with systemic lupus erythematosus (SLE) suffering from the membraneous form of Lupus nephritis (WHO class V). Therapeutic options used at present include azathioprine.
In a small, open label safety study, patients with lupus nephritis, including patients with membraneous lupus nephritis, have experienced a long-lasting therapeutic response, with sustained reduction in proteinuria, following a 10 weeks course of 4 infusions of infliximab in combination with azathioprine.
This short course appeared safe with regard to SLE activity, despite increases in autoantibody levels.
Study hypothesis:
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Erythematosus, Systemic Lupus Nephritis |
Drug: infliximab Drug: placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-Alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V Glomerulonephritis |
| Estimated Enrollment: | 44 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
azathioprine plus 4 infusions of infliximab (5 mg/kg)
|
Drug: infliximab
azathioprine (2 mg/lkg) plus four infusions of infliximab (5mg/kg)
|
|
2: Placebo Comparator
azathiorpine plus 4 placebo infusions
|
Drug: placebo
azathioprine (2 mg/kg) plus four placebo infusions
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening laboratory test results meet the following criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martin Aringer, MD | 43-1-40400 ext 4300 | martin.aringer@meduniwien.ac.at |
| Austria | |
| Rheumatology, Internal Medicine III, Medical University of Vienna | Recruiting |
| Vienna, Austria, A-1090 | |
| Principal Investigator: Martin Aringer, MD | |
| Principal Investigator: Clemens Scheinecker, MD | |
| Internal Medicine II, Hietzing Hospital | Recruiting |
| Vienna, Austria, A-1130 | |
| Principal Investigator: Peter Petera, MD | |
| Departments of Rheumatology, Internal Medicine, Medical University of Graz | Recruiting |
| Graz, Austria, A-8036 | |
| Principal Investigator: Winfried B Graninger, MD | |
| Germany | |
| Rheumatology, Charite | Recruiting |
| Berlin, Germany, D-10117 | |
| Contact: Falk Hiepe, MD falk.hiepe@charite.de | |
| Principal Investigator: Falk Hiepe, MD | |
| Internal Medicine III, University of Erlangen | Recruiting |
| Erlangen, Germany, D-91023 | |
| Principal Investigator: Reinhard Voll, MD | |
| Rheumatology, University of Düsseldorf | Recruiting |
| Düsseldorf, Germany, D-40225 | |
| Principal Investigator: Matthias Schneider, MD | |
| Rheumatology, University of Schleswig-Holstein, Campus Lübeck | Not yet recruiting |
| Lübeck, Germany, D-23538 | |
| Principal Investigator: Wolfgang L Gross, MD | |
| Netherlands | |
| Clinical Immunology, Groningen University Hospital | Recruiting |
| Groningen, Netherlands, 9713 GZ | |
| Contact: Marc Bilj, MD m.bijl@int.umcg.nl | |
| Principal Investigator: Marc Bijl, MD | |
| Leiden University Medical Center, Netherlands | Recruiting |
| Leiden, Netherlands, 2300 RC | |
| Principal Investigator: Stefan P Berger, MD | |
| Nephrology, University of Nymegen, Netherlands | Recruiting |
| Nijmegen, Netherlands, G6525 GA | |
| Principal Investigator: Jo H Berden, MD | |
| Study Chair: | Josef S Smolen, MD | Head, Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria |
| Principal Investigator: | Martin Aringer, MD | Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria |
| Principal Investigator: | Falk Hiepe, MD | Rheumatology, Charite, Berlin, Germany |
| Principal Investigator: | Marc Bijl, MD | Clinical Immunology, Groningen University Hospital, Netherlands |
More Information
| Responsible Party: | Department of Medicine III, Medical University of Vienna, Austria ( Prof. Josef S. Smolen, Head, Department of Medicine III ) |
| Study ID Numbers: | TRIAL V, Eudract-Nr. 2005-004067-30, Protocol EU-116, EK Nr:110/2006 |
| Study First Received: | August 23, 2006 |
| Last Updated: | May 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00368264 History of Changes |
| Health Authority: | Austria: Federal Ministry for Health and Women |
|
lupus nephritis membraneous proteinuria TNF |
infliximab azathioprine autoantibodies disease activity Systemic lupus erythematosus (SLE) with WHO class V nephritis |
|
Anti-Inflammatory Agents Antimetabolites Glomerulonephritis Autoimmune Diseases Immunologic Factors Lupus Nephritis Infliximab Lupus Immunosuppressive Agents Antibodies, Monoclonal Proteinuria |
Antibodies Azathioprine Autoantibodies Lupus Erythematosus, Systemic Urologic Diseases Nephritis Connective Tissue Diseases Kidney Diseases Antirheumatic Agents Immunoglobulins |
|
Anti-Inflammatory Agents Antimetabolites Glomerulonephritis Antimetabolites, Antineoplastic Autoimmune Diseases Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lupus Nephritis Infliximab Physiological Effects of Drugs |
Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Azathioprine Lupus Erythematosus, Systemic Urologic Diseases Therapeutic Uses Nephritis Connective Tissue Diseases Kidney Diseases Antirheumatic Agents Dermatologic Agents |