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

Lupus Nephritis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00573157
• Other study ID #: 28113
• Secondary ID: 493G01
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: December 11, 2007
• Last updated: July 1, 2014
• Start date: December 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2014
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• MMF
Mycophenolate mofetil(MMF)
• Atacicept plus MMF
Atacicept plus Mycophenolate mofetil (MMF)

Locations

Country	Name	City	State
Czech Republic	Institute of Rheumatology	Prague, 128 50
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
Singapore	Changi General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
United States	Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center	Beachwood	Ohio
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	1711 St. Julian Place	Columbia	South Carolina
United States	The Ohio State University Medical Center	Columbus	Ohio
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
United States	Southwest Rheumatology and Research Group, LLC	Middleburg Heights	Ohio
United States	Tulane University Hospital and Clinic Department of Internal Medicine	New Orleans,	Louisiana
United States	Seligman Center for Advanced Therapeutics	New York	New York
United States	ACME Research, LLC	Orangeburg	South Carolina
United States	Northwest Louisiana Nephrology Research	Shreveport	Louisiana
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono	ZymoGenetics

Countries where clinical trial is conducted

United States,  Czech Republic,  Malaysia,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the proportion of subjects with improvement in renal response to treatment.		The final measurements is at 52 weeks, and there is a total of 24 with follow-up after that	No
Secondary	Proportion of subjects with normalization of renal function; frequency of new lupus flares		Same as for primary	No