An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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).

Key facts

Study ID

NCT01273389

Run by

Janssen Research & Development, LLC

People needed

25

Starts

2011-08-01

Expected to finish

2013-09-01

Last updated by the study team

2016-03-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Lake Success, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Carrollton, Texas, United States
• Study site — Brussels, Belgium
• Study site — Leuven, Belgium
• Study site — Roeselare, Belgium
• Study site — Guadalajara, Mexico
• Study site — Guadalajara, Jalisco, Mexico
• Study site — México, Mexico
• Study site — Querétaro, Mexico
• Study site — Rotterdam, Netherlands
• Study site — Gdansk, Poland
• Study site — Warsaw, Poland
• Study site — Wroclaw, Poland
• Study site — Bangkok, Thailand
• Study site — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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