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

This study has been terminated.
Sponsor:
Collaborator:
ZymoGenetics
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00573157
First received: December 11, 2007
Last updated: July 1, 2014
Last verified: July 2014

December 11, 2007
July 1, 2014
December 2007
April 2009   (final data collection date for primary outcome measure)
The primary outcome is the proportion of subjects with improvement in renal response to treatment. [ Time Frame: The final measurements is at 52 weeks, and there is a total of 24 with follow-up after that ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00573157 on ClinicalTrials.gov Archive Site
Proportion of subjects with normalization of renal function; frequency of new lupus flares [ Time Frame: Same as for primary ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in patients with active lupus nephritis when taken in addition to mycophenolate mofetil and corticosteroids

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Lupus Nephritis
  • Drug: MMF
    Mycophenolate mofetil(MMF)
  • Drug: Atacicept plus MMF
    Atacicept plus Mycophenolate mofetil (MMF)
  • Placebo Comparator: 1
    Mycophenolate mofetil(MMF) alone
    Intervention: Drug: MMF
  • Active Comparator: 2
    Mycophenolate mofetil(MMF) plus atacicept
    Intervention: Drug: Atacicept plus MMF
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of 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 LN

Exclusion Criteria:

  • Estimated glomerular filtration rate (GFR) ≤30 mL/min per 1.73 m2
  • 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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Singapore,   Malaysia,   Czech Republic,   Taiwan
 
NCT00573157
28113, 493G01
Not Provided
Sally Anne Jones, Clinical Trial Manager, Clinical Trials Management, Zymogenetics
EMD Serono
ZymoGenetics
Study Director: Medical Responsible EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
EMD Serono
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP