Etanercept for the Treatment of Lupus Nephritis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00447265
• Date of registration: 12/03/2007
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: Etanercept for the Treatment of Lupus Nephritis
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Multi-Center Study for Treatment of Lupus Nephritis by Inhibition of Tumor Necrosis Factor-alpha Using Etanercept
• Date of first enrolment: February 2008
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00447265
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David Wofsy, MD
• Affiliation: Department of Medicine, University of California, San Francisco

• Name: Maria Dall'Era, MD
• Affiliation: Division of Rheumatology, University of California, San Francisco

Key inclusion & exclusion criteria

Inclusion Criteria:

- Meets at least 4 of the 11 American College of Rheumatology (ACR) 1982 Revised
Criteria for the Classification of SLE

- Active lupus nephritis

- Currently has antibodies to double-stranded DNA (dsDNA)

- Currently receiving treatment consisting of at least 1.5 g/day of MMF OR at least 720
mg/day orally of Mycophenolic Acid OR at least 1.5 mg/kg once per day of AZA for
lupus nephritis, for at least 28 days prior to study entry

- Stable medication regimen for at least 4 weeks prior to study entry

- Able and willing to self-administer study drug OR has a designated caregiver at home
to administer study drug injections

- Willing to use acceptable forms of contraception for the duration of the study

Exclusion Criteria:

- Moderately severe anemia

- Neutropenia

- Thrombocytopenia

- Blood creatinine levels greater than 3.0 mg/dl

- Positive PPD without ongoing treatment for at least 30 days prior to study entry

- Pulmonary fibrotic changes

- Active infections (e.g., HIV, hepatitis B virus [HBV], hepatitis C virus [HCV])
and/or serologic evidence of prior exposure to hepatitis B

- Received a live vaccine within 3 months prior to study entry

- Doubled serum creatinine levels within the 3 months prior to study entry OR end-stage
kidney disease

- Dialysis-dependent end-stage kidney disease or membranous nephritis

- History of cancer. Individuals with a history of cervical carcinoma in situ and
resected basal and squamous cell carcinomas of the skin are not excluded.

- Receiving prednisone greater than 20 mg/day or equivalent corticosteroid treatment

- Pulse intravenous methylprednisolone within 30 days prior to study entry

- Receiving immunosuppressive agents other than prednisone, MMF, Mycophenolic Acid,
AZA, or hydroxychloroquine

- Oral or intravenous cyclosporine, leflunomide IVIG, or plasmapheresis within 3 months
prior to study entry

- Current or previous cyclophosphamide treatment

- Use of other experimental agent within 90 days prior to study entry

- Severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart, or
brain disease. Individuals with any of these conditions that are related to active
SLE are not excluded.

- Previous use of rituximab within 12 months prior to study entry

- Previous or current exposure to any of the following: etanercept (Enbrel), adalimumab
(Humira), infliximab (Remicade), or anakinra (Kineret)

- Meets New York Heart Association classification of congestive heart failure (CHF)
Class III or greater

- History of myocardial infarction or ischemia

- Current or history of substance abuse

- Known hypersensitivity to any component of the study drug

- Poorly controlled or advanced diabetes mellitus

- History of multiple sclerosis, transverse myelitis, optic neuritis, or epilepsy

- History of noncompliance with other therapies

- Pregnancy or breastfeeding



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Intervention(s)

Drug: Etanercept

Drug: Lupus Treatment

Drug: Placebo

Primary Outcome(s)

Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study [Time Frame: 24 Weeks]

Secondary Outcome(s)

Number of Participant Adverse Events (AEs) From Baseline to Early Study Withdrawal Visit [Time Frame: 39 Weeks]

Number of Participants With a B to D Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Musculoskeletal Score [Time Frame: Baseline, Week 24]

Number of Participants With a C to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Mucocutaneous Score [Time Frame: Baseline, Week 24]

Number of Participants With an A to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Renal Score [Time Frame: Baseline, Week 24]

Participant Medical Outcome Study Short Form 36 (SF-36) Mental Component Score at Baseline and Week 24 [Time Frame: Baseline, Week 24]

Participant Medical Outcome Study Short-Form 36 (SF-36) Physical Component Score at Baseline and Week 24 [Time Frame: Baseline, Week 24]

Participant Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Baseline and at Early Study Withdrawal Visit [Time Frame: Baseline, Week 39 (Early Study Withdrawal Visit)]

Percent of Participants Who Achieved a Renal Response at Week 24 [Time Frame: Week 24]

Time to Participant's Renal Response [Time Frame: First 24 Weeks of Study Period]

Secondary ID(s)

DAIT ALN01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors