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

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Lupus Nephritis

Treatments

Drug: Placebo

Drug: Mycophenolate mofetil

Drug: Atacicept

Drug: Corticosteroids

Study type

Interventional

Funder types

Industry

Identifiers

NCT00573157

493G01

28113

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.