An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis
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|ClinicalTrials.gov Identifier: NCT01273389|
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : March 24, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Drug: CNTO 136 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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.
- 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 ]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 ]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 ]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 ]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 ]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 ]The Physician's Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS) (0 to 10 cm).
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of Systemic lupus erythematosus (SLE), and biopsy-proven International Society of Nephrology/Renal Pathology Society Class III or IV lupus glomerulonephritis within approximately 14 months prior to randomization
- Persistently active nephritis defined as, proteinuria greater than 0.5g/day as determined by measurement of total urine protein less than 0.5 g/24- hours or a urine Protein/Creatinine (P/C) ratio greater than 0.5 (mg/mg) in a timed collection of 12 or more hours, for 2 months or more prior to the first administration of study medication and observed during at least 2 visits conducted 1 week apart during the screening period
- Active Class III or Class IV lupus nephritis determined by recent biopsy within approximately 6 months prior to screening or at least 1 of the following 3 criteria: hematuria (blood in urine), anti-DNA positivity, or low C3 or C4 complement levels
- Stable immunosuppression for at least 9 weeks prior to the first administration of study medication consisting of MMF 1-3 g/day (or equivalent dose of MPA) with/without corticosteroids up to prednisone equivalent of 20 mg/day, or azathioprine 1-3 mg/kg/day with/without corticosteroids up to prednisone equivalent of 20 mg/day
- Stable dose of angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blocker (ARB) for at least 9 weeks prior to the first administration of study medication
- If using oral corticosteroids, must be on a stable dose equivalent to 20 mg/day or less of prednisone for at least 9 weeks prior to the first administration of study medication
- Cyclophosphamide use within 3 months of randomization
- B-cell depletion therapy within 6 months of screening, or evidence of persistent B-cell depletion at the time of screening
- Greater than 50 percent glomerular sclerosis on renal biopsy
- Serum creatinine > 2.5 mg/dL (SI: > 177 µmol/L)
- White blood cell count < 3.5 x 10^3 cells/µL (SI: < 3.5 x 10^9 cells/L) or neutrophils < 1.96 x 10^3 cells/µL (SI: < 1.96 x 10^9 cells/L)
- Platelets < 140 x 103 cells/ µL (SI: < 140 x 10^9 cells/L)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273389
|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|
|Responsible Party:||Janssen Research & Development, LLC|
|Other Study ID Numbers:||
CNTO136LUN2001 ( Other Identifier: Janssen Research & Development, LLC )
2010-020968-38 ( EudraCT Number )
|First Posted:||January 10, 2011 Key Record Dates|
|Last Update Posted:||March 24, 2016|
|Last Verified:||February 2016|
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases