Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

Inclusion Criteria:

- Adults between 18 and 80 years of age, inclusive

- Diagnosis of SLE by ACR criteria and biopsy-proven ISN/RPS Class III or IV lupus
glomerulonephritis within 2 years

- Persistently active nephritis defined as proteinuria greater than or equal to 1.0
g/day for 3 months or more, AND at least 1 of the following:

- Hematuria (greater than or equal to 5 RBC/hpf) on 2 or more urinalyses done
greater than or equal to 2 weeks apart

- anti-dsDNA positive or anti-Smith positive, or

- low C3 or C4 complement level. (d) Stable immunosuppression consisting of
mycophenolate mofetil (MMF) 13 g/day with/without corticosteroids up to
prednisone equivalent of 15 mg/day, or azathioprine 13 mg/kg/day with/without
corticosteroids up to prednisone equivalent of 20 mg/day.

- Stable dose of ACE inhibitor/ARB for 4 weeks prior to study enrollment, unless
previously intolerant to or having a contraindication to ACE inhibitors and ARBs

- If using oral corticosteroids, must be on a stable dose equivalent to less than or
equal to 15 mg/day of prednisone for at least 4 weeks prior to study enrollment. If
currently not using corticosteroids, the subject must not have received oral
corticosteroids for at least 4 weeks prior study enrollment.

- Clarification of inclusion criteria for controls: Any patient with an idiopathic
glomerular disease who does not have lupus nephritis. This includes patients with
minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis,
and IgA nephropathy.

Exclusion Criteria:

- B-cell depletion therapy in past 1 yr, or evidence of persistent B cell depletion at
the time of screening.

- Received an investigational drug (including vaccines) or used an investigational
medical device within 3 months of study enrollment or within 5 half-lives of agent,
whichever is longer.