Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Study ID
IM101-291

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Contact
Azza Badr
214/648-7219
azza.mutwally@utsouthwestern.edu

Principal Investigator
David Karp

Official Title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis

Brief Overview


The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when
used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

Participant Eligibility


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

Inclusion Criteria:

- 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

Inclusion Criteria for the Long-Term Extension Period:

- Signed Written Informed Consent

- Subjects who achieve a complete or partial renal response after completing 2 years of
double-blind treatment

Exclusion Criteria:

- 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