Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Note: Subjects \> 16 are eligible for enrollment at selected centers
Potential subjects must have active lupus nephritis
Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney)
Urine protein creatinine ratio (UPCR) ≥ 1 at Screening
Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)
There must also be evidence of active disease within 3 months of Screening, based on at least one of the following:
* Worsening of lupus nephritis OR
* UPCR ≥ 3 at Screening OR
* Active urine sediment OR
* Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis
Signed Written Informed Consent
Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment
You may not be if
Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis
Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study
Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive
Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible
