Efficacy and Safety Study of Abatacept to treat Lupus Nephritis

Phase 1

• Conditions: Active Class III or IV lupus glomerulonephritis; MedDRA version: 17.0Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-000714-11-RO
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-25
• Study Completion: 2018-05-30
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 695

Inclusion Criteria

a) 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 at Screening
c) Biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-G (C)] or WHO 1982 Classification Class III or IV (excluding IIIc, IVd).
d) Evidence of active disease within 3 months of Screening, based on at least one of the following:
i) Renal Flare
ii) UPCR = 3 at Screening
iii) Active urine sediment, defined as at least one of the following:
•= 5 red blood cells (RBC) per high power field (hpf)
•= 5 white blood cells (WBC) per hpf
•presence of cellular casts
iv) Biopsy within 3 months prior to screening visit indicating active proliferative lupus glomerulonephritis.
e) Serum creatinine = 3 mg/dL (ie, = 265 micromol/L).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 539
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 (eg; RA, MS).
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 CNS lupus (BILAG A or B) with the exception of fatigue or mild stable cognitive dysfunction (screening 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 clinical trial of medicinal product
• Study Design: Not specified