An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate Efficacy and Safety of Treatment With CNTO 136 Administered Intravenously in Subjects With Active Lupus Nephritis|
- 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) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]It is measured as the percentage in reduction of proteinuria from baseline to Week 24.
- Number of patients with a reduction from baseline in proteinuria by at least 50% [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]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.
- Number of patients with a meaningful reduction in proteinuria [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]It is measured as the proportion of patients with meaningful reduction of proteinuria at any time through Week 24.
- Number of patients with no worsening in Glomerular Filtration Rate (GFR) [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]It is measured as the proportion of patients with no worsening in GFR at any time through Week 24.
- Patient's Global Assessment of Disease Activity [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]The Patient's Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS) (0 to 10 cm).
- Physician's Global Assessment of Disease Activity [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]The Physician's Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS) (0 to 10 cm).
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: CNTO 136
CNTO 136 is used in the form of final vialed product, as a single-use, sterile solution in a 2 ml glass vial. Each 1 mL of the solution contains sirukumab 100mg active drug substance, sorbitol, acetate buffer, and polysorbate 20, at a pH of 5.0, without any preservatives.
Drug: CNTO 136
Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous. CNTO 136 is administered once every 4 weeks from Week 0 to Week 24.
|Placebo Comparator: Placebo||
Form=solution for injection, route=intravenous. Placebo is administered once every 4 weeks from Week 0 to Week 24.
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.
|United States, Alabama|
|Birmingham, Alabama, United States|
|United States, California|
|Los Angeles, California, United States|
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, New York|
|Lake Success, New York, United States|
|United States, Ohio|
|Columbus, Ohio, United States|
|United States, Pennsylvania|
|Duncansville, Pennsylvania, United States|
|United States, Tennessee|
|Chattanooga, Tennessee, United States|
|United States, Texas|
|Carrollton, Texas, United States|
|Guadalajara, Jalisco, Mexico|
|Chiang Mai, Thailand|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|