Trial record 1 of 1 for:
NCT00573157
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
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| ClinicalTrials.gov Identifier: NCT00573157 |
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Recruitment Status :
Terminated
(The study was terminated due to unanticipated safety issues)
First Posted : December 14, 2007
Results First Posted : March 23, 2016
Last Update Posted : March 23, 2016
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Sponsor:
EMD Serono
Collaborator:
ZymoGenetics
Information provided by (Responsible Party):
EMD Serono
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lupus Nephritis | Drug: Atacicept Drug: Mycophenolate mofetil Drug: Placebo Drug: Corticosteroids | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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. |
| Study Start Date : | December 2007 |
| Actual Primary Completion Date : | April 2009 |
| Actual Study Completion Date : | April 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Atacicept Plus Mycophenolate mofetil Plus Corticosteroids |
Drug: Atacicept
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. Drug: Mycophenolate mofetil 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. Drug: Corticosteroids 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. |
| Placebo Comparator: Placebo Plus Mycophenolate mofetil Plus Corticosteroids |
Drug: Mycophenolate mofetil
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. Drug: Placebo 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. Drug: Corticosteroids 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. |
Primary Outcome Measures :
- Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response [ Time Frame: 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 :
- Percentage of Participants With Normalization of Renal Function [ Time Frame: At Week 52 ]
- Number of Participants With New Lupus Flares [ Time Frame: At Week 52 ]
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00573157 History of Changes |
| Other Study ID Numbers: |
28113 493G01 |
| First Posted: | December 14, 2007 Key Record Dates |
| Results First Posted: | March 23, 2016 |
| Last Update Posted: | March 23, 2016 |
| Last Verified: | February 2016 |
Keywords provided by EMD Serono:
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nephritis atacicept |
Additional relevant MeSH terms:
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Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Mycophenolic Acid Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |