None listed
Conditions
Interventions
Investigational product will be administered as an IV infusion via an infusion pump over no less than 60 minutes for the first 12 weeks (Visit 1, 2 and 3). Starting with Visit 4,
investigational pr
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. In the opinion of the investigator, must be able to understand the informed consent form (ICF), and all protocol-related subject assessments 2. Fulfils at least 4 of the 11 ACR classification criteria for SLE (see Appendix D), one of which must be: (a) Positive antinuclear antibody (ANA) test (1:40 or higher) at screening by immunofluorescence assay at central laboratory; or (b) (Elevated anti-dsDNA or anti-Sm antibody at screening as determined by central laboratory Clinical criteria may have been present by history if documented in the medical record. Laboratory values specified above must be determined to be positive at screening. 3. Diagnosis of proliferative LN based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period: - Class III (±class V) or class IV (±class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification (based on local evaluation of renal biopsy) 4. Urine protein to creatinine ratio >1 gm/gm, obtained on a 24-hour urine collection at both: - The start of screening and - Between Day -14 and -7 of expected date of randomization FOR MORE INFORMATION PLEASE SEE PROTOCOL
Exclusion criteria
Exclusion criteria: 1. Known intolerance to ≤1.5 gm/day of MMF 2. Lactating or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of screening through the 12-week safety follow-up period following last dose of investigational product 3. A diagnosis of pure Class V membranous LN. This will be based on the renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period 4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment 5. History of, or current renal diseases (other than LN) that in the opinion of the Investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy) FOR MORE INFORMATION PLEASE SEE PROTOCOL
Countries
Argentina, Australia, Belgium, France, Germany, Hungary, Italy, Korea South, Mexico, Poland, Russian Federation, Serbia, South Africa, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed