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

Phase 2

Terminated

• Conditions: Lupus Nephritis
• Interventions: Drug: Atacicept; Drug: Mycophenolate mofetil; Drug: Placebo; Drug: Corticosteroids

• Registration Number: NCT00573157
• Lead Sponsor: EMD Serono

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-14
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2016-02
• Results First Submitted: 2016-02-22
• Results First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Results First Posted: 2016-03-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids	Atacicept	-
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids	Corticosteroids	-
Placebo Plus Mycophenolate mofetil Plus Corticosteroids	Mycophenolate mofetil	-
Placebo Plus Mycophenolate mofetil Plus Corticosteroids	Placebo	-
Placebo Plus Mycophenolate mofetil Plus Corticosteroids	Corticosteroids	-
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids	Mycophenolate mofetil	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response	At Week 52	Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate \[GFR\]), improvement in proteinuria (urine protein/creatinine ratio \<0.5) \& resolution of hematuria. Partial response (PR): from baseline, a \<= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) \& resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Normalization of Renal Function	At Week 52
Number of Participants With New Lupus Flares	At Week 52

Trial Locations

Locations (20)

1711 St. Julian Place; 🇺🇸 Columbia, South Carolina, United States

The Feinstein Institute for Medical Research; 🇺🇸 Manhasset, New York, United States

Hospital Sultanah Bahiyah; 🇲🇾 Kedah, Malaysia

Northwest Louisiana Nephrology Research; 🇺🇸 Shreveport, Louisiana, United States

Seligman Center for Advanced Therapeutics; 🇺🇸 New York, New York, United States

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Institute of Rheumatology; 🇨🇿 Prague, 128 50, Czech Republic

Singapore General Hospital; 🇸🇬 Singapore, Singapore

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

University of Cincinnati College of Medicine; 🇺🇸 Cincinnati, Ohio, United States

Tulane University Hospital and Clinic Department of Internal Medicine; 🇺🇸 New Orleans,, Louisiana, 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

Southwest Rheumatology and Research Group, LLC; 🇺🇸 Middleburg Heights, Ohio, United States

University of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

Hospital University Kebangsaan Malaysia; 🇲🇾 Kuala Lumpur, Malaysia

Hospital Pulau Pinang; 🇲🇾 Pulau Pinang, Malaysia

Changi General Hospital; 🇸🇬 Singapore, Singapore

ACME Research, LLC; 🇺🇸 Orangeburg, South Carolina, United States