Status:
TERMINATED
Etanercept for the Treatment of Lupus Nephritis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Systemic lupus erythematosus (SLE) is a chronic, multisystem, autoimmune disease in which the body's immune system attacks its own normal tissues. This abnormal autoimmune response can result in damag...
Detailed Description
Kidney problems associated with lupus nephritis range from asymptomatic protein in the urine to rapidly progressive glomerulonephritis, leading to end-stage renal disease. The goal of therapies is to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00447265
Start Date
February 1 2008
End Date
March 1 2009
Last Update
February 12 2013
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California at San Francisco
San Francisco, California, United States, 94143
3
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
4
Feinstein Institute for Medical Research NS-L1J Health System
Manhasset, New York, United States, 11030