Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis.

Phase 3

Completed

• Conditions: upus Nephritis

• Registration Number: JPRN-jRCT2080222074
• Lead Sponsor: Bristol-Myers Squibb K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Major
a) Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincidentally.
b) Urine protein creatinine ratio (UPCR) 1.0 or more than 1.0 at Screening.
c) Biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis International Society of Nephrology (ISN)/ Renal Pathology Society (RPS) 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-G (C)] or World Health Organization (WHO) 1982 Classification Class III or IV (excluding IIIc, IVd).
d) Evidence of active disease within 3 months of Screening.
e) Serum creatinine 3 or less than 3 mg/dL.

Exclusion Criteria

Key Exclusion Criteria:
a) Subjects with drug-induced SLE, as opposed to idiopathic SLE.
b) Subjects with autoimmune disease other than SLE as their main diagnosis.
c) 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.
d) Active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive dysfunction [screening Magnetic Resonating Imaging (MRI) or other imaging of the brain is not required to rule-out CNS disease in subjects who have no clinical features suggesting active CNS disease].
e) Subjects who are diagnosed as end-stage renal disease.
f) Subjects with persistent non-lupus related pyuria or hematuria (eg, hemorrhagic cystitis).
g) Subjects with a degree of tubulo-interstitial changes that suggests a significant and irreversible decrease in renal function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified