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

NCT01273389 | Completed Phase 2

• 3 other identifiers: CR017551CNTO136LUN20012010-020968-38
• Study Type: interventional
• Target: 25
• Locations: 6 countries
• Sites: 21

Brief Summary

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).

Conditions

Lupus Nephritis

Keywords

Lupus nephritis; CNTO 136; Sirukumab; Kidney diseases; Proteinuria; Glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• 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)

  It is measured as the percentage in reduction of proteinuria from baseline to Week 24.

  Baseline to Week 24

Secondary Outcomes (5)

• Number of patients with a reduction from baseline in proteinuria by at least 50%

  Up to Week 24

• Number of patients with a meaningful reduction in proteinuria

  Up to Week 24

• Number of patients with no worsening in Glomerular Filtration Rate (GFR)

  Up to Week 24

• Patient's Global Assessment of Disease Activity

  Up to Week 24

• Physician's Global Assessment of Disease Activity

  Up to Week 24

Study Arms (2)

CNTO 136

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CNTO 136 DRUG

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.

CNTO 136

Placebo DRUG

Form=solution for injection, route=intravenous. Placebo is administered once every 4 weeks from Week 0 to Week 24.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (21)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Lake Success, New York, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Carrollton, Texas, United States

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Roeselare, Belgium

Location

Unknown Facility

Guadalajara, Mexico

Location

Unknown Facility

Guadalajara, Jalisco, Mexico

Location

Unknown Facility

México, Mexico

Location

Unknown Facility

Querétaro, Mexico

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Related Publications (1)

• Rovin BH, van Vollenhoven RF, Aranow C, Wagner C, Gordon R, Zhuang Y, Belkowski S, Hsu B. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Treatment With Sirukumab (CNTO 136) in Patients With Active Lupus Nephritis. Arthritis Rheumatol. 2016 Sep;68(9):2174-83. doi: 10.1002/art.39722.

  PMID: 27110697 DERIVED

MeSH Terms

Conditions

Lupus Nephritis; Kidney Diseases; Proteinuria; Glomerulonephritis

Interventions

sirukumab

Condition Hierarchy (Ancestors)

Nephritis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 24, 2016

Record last verified: 2016-02

Locations

BE (3); NL (1); US (8); PL (3); TH (2); ME (4)