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



Status:Completed
Conditions:Lupus, Renal Impairment / Chronic Kidney Disease, Nephrology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:August 2011
End Date:September 2013

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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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)
We found this trial at
9
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Chattanooga, TN
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Duncansville, Pennsylvania 16635
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