Study Stopped
The study was terminated due to unanticipated safety issues
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
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.
2 other identifiers
interventional
6
5 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2007
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
March 23, 2016
CompletedMarch 23, 2016
February 1, 2016
1.3 years
December 11, 2007
February 22, 2016
February 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
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.
At Week 52
Secondary Outcomes (2)
Percentage of Participants With Normalization of Renal Function
At Week 52
Number of Participants With New Lupus Flares
At Week 52
Study Arms (2)
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids
EXPERIMENTALPlacebo Plus Mycophenolate mofetil Plus Corticosteroids
PLACEBO COMPARATORInterventions
Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks.
MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.
High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
- ZymoGeneticscollaborator
Study Sites (20)
Tulane University Hospital and Clinic Department of Internal Medicine
New Orleans, Louisiana, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, 71101, 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, 11030, United States
Seligman Center for Advanced Therapeutics
New York, New York, 10003, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27109, United States
Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
Beachwood, Ohio, 44122, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Southwest Rheumatology and Research Group, LLC
Middleburg Heights, Ohio, 44130, United States
1711 St. Julian Place
Columbia, South Carolina, 29204, United States
ACME Research, LLC
Orangeburg, South Carolina, 29118, 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
Related Publications (1)
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.
PMID: 22325903DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated due to unanticipated safety issues.
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Serono, a division of Merck KGaA
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 14, 2007
Study Start
December 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
March 23, 2016
Results First Posted
March 23, 2016
Record last verified: 2016-02