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View Clinical Trial (Medical Research Study)
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Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis - NCT00774852-92037 (Clinical Trial 248182)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy248182.aspx
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| City: |
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La Jolla |
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State:
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CA |
| Zip Code: |
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92037 |
| Conditions: |
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Lupus Nephritis - Lupus Erythematosus, Systemic |
| Purpose: |
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This study is for people with lupus who have developed complications in their kidneys, or
lupus nephritis. The study will determine whether adding the experimental medication
abatacept to standard cyclophosphamide therapy is more effective in improving lupus
nephritis than standard cyclophosphamide therapy by itself.
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| Study summary: |
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Lupus nephritis is a kind of kidney inflammation that occurs in patients with systemic lupus
erythematosus (SLE). It is caused by the immune system attacking the kidney. It is among the
most serious complications of SLE, and left untreated it can cause long term damage to the
kidneys or, in some cases, result in kidney failure.
One of the more common treatments for lupus nephritis is the "Euro-lupus" therapy. In this
therapy, patients receive three different drugs - cyclophosphamide, azathioprine and
prednisone - over the course of several months. However, some patients do not respond to
this therapy and many only show some improvement.
In the ACCESS trial for lupus nephritis, an experimental medication known as abatacept will
be added to the Euro-lupus therapy to find out if it works better than Euro-lupus therapy
alone. Abatacept is a man-made protein that suppresses parts of the immune system that can
cause autoimmune disease. While abatacept is experimental for lupus, it has been approved by
the FDA to treat rheumatoid arthritis. It is also being studied for use in other autoimmune
diseases, like multiple sclerosis and type 1 diabetes.
Participants in the ACCESS trial for lupus nephritis will receive bi-weekly intravenous
infusions of cyclophosphamide for 3 months, then will take azathioprine tablets daily for at
least 3 months more. Abatacept or a placebo will be administered every 2 weeks at first,
then every 4 weeks for at least the first 6 months. Treatment of abatacept or placebo and
azathioprine may continue for the remainder of the year. All subjects will take prednisone
tablets daily during the whole study.
Because the ACCESS trial is a randomized, controlled study, each participant has a 50-50
chance (like flipping a coin) of receiving abatacept. Others will receive an inactive,
placebo form of the drug. Note however, that all participants will receive the Euro-lupus
therapy. As a blinded study, neither participants nor study physicians will know to which
group a person has been assigned.
All participants will undergo regular physical examinations, medical history and various
blood and urine tests. Many of these tests will be repeated throughout the study.
Participants will be asked to attend 18 study visits in the first year, and one study visit
at the end of the second year.
The study will reimburse participants for certain expenses incurred as part of the study. |
| Criteria: |
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Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology
(ACR) criteria
- Active lupus nephritis (defined by: kidney biopsy documentation within the last 12
months of ISN/RPS proliferative nephritis, active urinary sediment, urine
protein-to-creatinine ratio > 1, low C3)
- Positive antinuclear antibody (ANA) test results at time of study entry.
Exclusion Criteria:
- end stage renal disease
- use of cyclophosphamide in the past year
- neutropenia, thrombocytopenia, moderately severe anemia
- active infection, including HIV, hepatitis B or C
- history of cancer, except carcinoma in situ and treated basal and squamous cell
carcinomas
- pregnant or breastfeeding |
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| Study is available at: |
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University of California San Diego
La Jolla, CA 92037
United States
Primary Contact:
Gabriela Evia
Email: gevia@ucsd.edu
Phone: 858-657-7043 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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