Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
1986-11-30
2004-09-30
Brief Summary
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This study will evaluate the effectiveness and toxic effects of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month period. The major goal of this therapy is to decrease protein losses and ultimately prevent kidney failure.
Patients enrolled in the study will undergo a routine history and physical examination. In addition, several diagnostic tests will be conducted including; chest x-ray ECG, blood and urine laboratory tests.
Patients will be divided and grouped according to the severity of their disease as shown by kidney function. Each group will then randomly be subcategorized by different treatment plans. Each treatment plan will made up of immunosuppressive medications including prednisone, cyclophosphamide, cyclosporin A, and combinations of these drugs. Patients will receive the medications as directed by the study.
The study will last 12 months and require patients to be admitted for two to five days before the study begins and once the study is completed. Patients will be followed as outpatients throughout the 12 month study.
Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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prednisone
cyclophosphamide
cyclosporin A
Eligibility Criteria
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Inclusion Criteria
SLE as defined by the presence of at least 4 criteria established by the American Rheumatism Association.
Age 12 years or older.
Membranous lupus nephropathy manifested by 2 or more grams per day of proteinuria in the absence of infection or recognized non-lupus renal disease. A renal biopsy must reveal typical membranous lupus nephropathy by light microscopy. Immune deposits must be predominately sub-epithelial and/or intramembranous in location by electron microscopy.
Exclusion Criteria
* cytotoxic drugs or cyclosporin A for more than 2 weeks during the 10 week period prior to study entry.
* cytotoxic drug therapy or cyclosporin A for more than 10 weeks at anytime in the past.
* cytotoxic drug therapy or cyclosporin A during the 30 day period prior to study entry.
* requirement of corticosteroids in doses greater than 20 mg/m(2)/day of prednisone (or equivalent) for control of extrarenal disease at the time of study entry.
Active acute or chronic infection requiring antimicrobial therapy, or serious viral infection (eg. hepatitis, herpes zoster).
Pregnant females, nursing mothers, or females not practicing birth control.
Patients with a single functioning kidney.
Pre-existent malignancy.
Insulin-treated diabetes mellitus.
GFR less than 25 ml/min/1.73m(2) BSA.
Known toxicity to cyclophosphamide.
Positive tests for HIV infection.
Furthermore, patients with any one of the following conditions (related to the use of cyclosporin A) will be excluded from randomization within renal function group 2 (Glomerular filtration rate greater than 66 ml/min/1.73m(2)):
* Renal biopsy revealing global sclerosis of greater than 50 percent of glomeruli, severe tubular atrophy, or severe interstitial fibrosis.
* Persistently abnormal and unexplained liver function abnormalities (defined as elevated transaminases, bilirubin, or alkaline phosphatase twice the upper limit of normal for at least 1 month) or evidence of active viral hepatitis.
* Hypertension difficult to control or uncontrollable with conventional anti-hypertensive regimens.
* Documented coronary artery disease.
* Convulsive disorders.
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Locations
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States
Countries
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References
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Donadio JV Jr, Burgess JH, Holley KE. Membranous lupus nephropathy: a clinicopathologic study. Medicine (Baltimore). 1977 Nov;56(6):527-36. doi: 10.1097/00005792-197711000-00007.
Baldwin DS, Lowenstein J, Rothfield NF, Gallo G, McCluskey RT. The clinical course of the proliferative and membranous forms of lupus nephritis. Ann Intern Med. 1970 Dec;73(6):929-42. doi: 10.7326/0003-4819-73-6-929. No abstract available.
Baldwin DS, Gluck MC, Lowenstein J, Gallo GR. Lupus nephritis. Clinical course as related to morphologic forms and their transitions. Am J Med. 1977 Jan;62(1):12-30. doi: 10.1016/0002-9343(77)90345-x.
Other Identifiers
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86-DK-0204
Identifier Type: -
Identifier Source: secondary_id
860204
Identifier Type: -
Identifier Source: org_study_id