The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis - Full Text View

Purpose

The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in patients with active lupus nephritis when taken in addition to mycophenolate mofetil and corticosteroids

Condition	Intervention	Phase
Lupus Nephritis	Drug: MMF Drug: Atacicept plus MMF	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects With Lupus Nephritis in Combination With Mycophenolate Mofetil Therapy.

Resource links provided by NLM:

Drug Information available for: Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate mofetil

Genetic and Rare Diseases Information Center resources: Glomerulonephritis Lupus Nephritis

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

The primary outcome is the proportion of subjects with improvement in renal response to treatment. [ Time Frame: The final measurements is at 52 weeks, and there is a total of 24 with follow-up after that ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with normalization of renal function; frequency of new lupus flares [ Time Frame: Same as for primary ] [ Designated as safety issue: No ]


Enrollment:	6
Study Start Date:	December 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Mycophenolate mofetil(MMF) alone	Drug: MMF Mycophenolate mofetil(MMF)
Active Comparator: 2 Mycophenolate mofetil(MMF) plus atacicept	Drug: Atacicept plus MMF Atacicept plus Mycophenolate mofetil (MMF)

Eligibility


Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of SLE satisfying at least 4 out of the 11 American College of Rheumatology (ACR) criteria (Appendix B)
Renal biopsy performed consistent with active International Society of Nephrology/Renal Pathology Society (ISN/PRS) class III or IV LN

Exclusion Criteria:

Estimated glomerular filtration rate (GFR) ≤30 mL/min per 1.73 m2
Active central nervous system SLE deemed to be severe or progressive and/or associated with significant cognitive impairment
Any treatment with MMF, azathioprine, or cyclophosphamide within the last 6 months, or known hypersensitivity to MMF or atacicept.
Any prior treatment with abatacept, rituximab, belimumab, or other B cell modulating agents.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573157

Locations


United States, Louisiana
Tulane University Hospital and Clinic Department of Internal Medicine
New Orleans,, Louisiana, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, United States, 71101
United States, Michigan
Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine
Detroit, Michigan, United States
United States, New York
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Seligman Center for Advanced Therapeutics
New York, New York, United States, 10003
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27109
United States, Ohio
Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
Beachwood, Ohio, United States, 44122
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Southwest Rheumatology and Research Group, LLC
Middleburg Heights, Ohio, United States, 44130
United States, South Carolina
1711 St. Julian Place
Columbia, South Carolina, United States, 29204
ACME Research, LLC
Orangeburg, South Carolina, United States, 29118
Czech Republic
Institute of Rheumatology
Prague, 128 50, Czech Republic
Malaysia
Hospital Sultanah Bahiyah
Kedah, Malaysia
Hospital University Kebangsaan Malaysia
Kuala Lumpur, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Malaysia
Singapore
Changi General Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan

Sponsors and Collaborators

EMD Serono

ZymoGenetics

Investigators


Study Director:	Medical Responsible	EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany

More Information

No publications provided by EMD Serono

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ginzler EM, Wax S, Rajeswaran A, Copt S, Hillson J, Ramos E, Singer NG. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther. 2012 Feb 7;14(1):R33. doi: 10.1186/ar3738.


Responsible Party:	Sally Anne Jones, Clinical Trial Manager, Clinical Trials Management, Zymogenetics
ClinicalTrials.gov Identifier:	NCT00573157 History of Changes
Other Study ID Numbers:	28113, 493G01
Study First Received:	December 11, 2007
Last Updated:	July 1, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Lupus Nephritis Nephritis Autoimmune Diseases Connective Tissue Diseases Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Urologic Diseases Mycophenolate mofetil	Mycophenolic Acid Antibiotics, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015