Clinical trial NCT00573157: The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Lupus Nephritis
Keywords: nephritis
atacicept
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: ZymoGenetics
First posted: 2007-12-14
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
timeFrame: At Week 52
Secondary outcomes:
measure: Percentage of Participants With Normalization of Renal Function
timeFrame: At Week 52
measure: Number of Participants With New Lupus Flares
timeFrame: At Week 52
Other outcomes:
Locations:
city: New Orleans,
country: United States
facility: Tulane University Hospital and Clinic Department of Internal Medicine
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology Research
state: Louisiana
city: Detroit
country: United States
facility: Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine
state: Michigan
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Seligman Center for Advanced Therapeutics
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Beachwood
country: United States
facility: Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Rheumatology and Research Group, LLC
state: Ohio
city: Columbia
country: United States
facility: 1711 St. Julian Place
state: South Carolina
city: Orangeburg
country: United States
facility: ACME Research, LLC
state: South Carolina
city: Prague, 128 50
country: Czech Republic
facility: Institute of Rheumatology
city: Kedah
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Kuala Lumpur
country: Malaysia
facility: Hospital University Kebangsaan Malaysia
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.