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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics.

Key facts

Study ID

NCT00573157

Run by

EMD Serono

People needed

6

Starts

2007-12-01

Expected to finish

2009-04-01

Last updated by the study team

2016-03-23

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of systemic lupus erythematosus (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 lupus nephritis

You may not qualify if…

• Estimated glomerular filtration rate (GFR) less than or equal to (<=) 30 milliliter per minute (mL/min) per 1.73 square meter (m\^2)
• 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.

Where it is running

• Tulane University Hospital and Clinic Department of Internal Medicine — New Orleans, Louisiana, United States
• Northwest Louisiana Nephrology Research — Shreveport, Louisiana, United States
• 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
• The Feinstein Institute for Medical Research — Manhasset, New York, United States
• Seligman Center for Advanced Therapeutics — New York, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center — Beachwood, Ohio, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Southwest Rheumatology and Research Group, LLC — Middleburg Heights, Ohio, United States
• 1711 St. Julian Place — Columbia, South Carolina, United States
• ACME Research, LLC — Orangeburg, South Carolina, United States
• Institute of Rheumatology — Prague, 128 50, Czechia
• 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
• Changi General Hospital — Singapore, Singapore
• Singapore General Hospital — Singapore, Singapore
• Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan

Full record on ClinicalTrials.gov

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