Active Lupus Nephritis MedDRA version: 14.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Code: CNTO136
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: CNTO 136
Other descriptive name: fully human anti-IL-6 mAb
Concentration unit: mg milligram(s)
Concen
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy and safety of CNTO 136 administered intravenously (IV) in subjects with active, International Society of Nephrology (ISN)/Renal Pathology Society (RPS) Class III and IV lupus nephritis (LN).;Secondary Objective: - Evaluate the pharmacokinetics and immunogenicity of CNTO 136 following IV administration in subjects with active ISN/RPS Class III and IV LN - Assess the pharmacodynamic effects of CNTO 136 IV in subjects with active ISN/RPS Class III and IV LN;Primary end point(s): The primary endpoint is the percent reduction from baseline in proteinuria at Week 24. A 95% confidence interval of the mean change will be calculated based on normal approximation. The baseline value for proteinuria will be defined as the average of the two most recent proteinuria measurements preceding the first study agent infusion. The major secondary endpoints are proportion of subjects with a reduction from baseline in proteinuria by at least 50% at any time through Week 24; proportion of subjects with a meaningful reduction in proteinuria at any time through Week 24; and proportion of subjects with no worsening in GFR at any time through Week 24.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in Patient’s and Physician’s Global Assessment of Disease Activity at Week 24 will be summarized by treatment group.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Belgium, Mexico, Netherlands, Poland, Thailand, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed