The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered intravenously in patients with active, International Society of Nephrology/Renal Pathology Society Class III and IV Lupus Nephritis (LN).
This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither investigator nor the patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), parallel group (each group of patients will be treated at the same time) study of CNTO 136 in patients with active LN. The study consists of 3 phases, ie, the screening phase (approximately 8 weeks prior randomization), treatment phase (24 weeks), and the follow up phase (through week 40). An 8 week run-in period will be used to establish the stability of baseline renal parameters prior to randomization and the first study medication. The eligible patients will be randomly assigned in a 5:1 ratio to receive 1 of 2 treatment groups in the treatment phase: Group 1: CNTO 136 10 mg/kg intravenous (IV), at Weeks 0, 4, 8, 12, 16, 20, 24; and Group 2: Placebo infusion, IV, at Weeks 0, 4, 8, 12, 16, 20, 24. Patients' medication regimen for LN may be adjusted from the Week 24 visit and afterwards. Safety evaluations for adverse events, infections, clinical laboratory tests, electrocardiogram, vital signs, physical examination and skin evaluations will be performed throughout the study. The follow up phase or the end of study will be the Week 40 visit for the last patient randomized, or, in the event that the last patient randomized withdraws from the study early, the end of study is defined as the date of the last visit of the last patient participating in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Chicago, Illinois, United States
Number of patients with reduction in proteinuria (measurement of total urine protein greater than 0.5 g/24-hours, or a urine protein to creatinine ratio greater than 0.5 mg/mg)
It is measured as the percentage in reduction of proteinuria from baseline to Week 24.
Time frame: Baseline to Week 24
Number of patients with a reduction from baseline in proteinuria by at least 50%
It is measured as the proportion of patients with a reduction from baseline in proteinuria by at least 50% at any time through Week 24.
Time frame: Up to Week 24
Number of patients with a meaningful reduction in proteinuria
It is measured as the proportion of patients with meaningful reduction of proteinuria at any time through Week 24.
Time frame: Up to Week 24
Number of patients with no worsening in Glomerular Filtration Rate (GFR)
It is measured as the proportion of patients with no worsening in GFR at any time through Week 24.
Time frame: Up to Week 24
Patient's Global Assessment of Disease Activity
The Patient's Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS) (0 to 10 cm).
Time frame: Up to Week 24
Physician's Global Assessment of Disease Activity
The Physician's Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS) (0 to 10 cm).
Time frame: Up to Week 24
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Unnamed facility
Lake Success, New York, United States
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Duncansville, Pennsylvania, United States
Unnamed facility
Chattanooga, Tennessee, United States
Unnamed facility
Carrollton, Texas, United States
Unnamed facility
Brussels, Belgium
Unnamed facility
Leuven, Belgium
...and 11 more locations