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| Name | Class |
|---|---|
| Centocor Research & Development, Inc. | INDUSTRY |
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This is an exploratory study. No formal hypothesis will be tested.
The objectives of this study are to follow Lupus Nephritis patients over a period of 12 months to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lupus Nephritis Patients |
| ||
| Control Patients | Any patient with an idiopathic glomerular disease who does not have lupus nephritis. This includes patients with minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis, and IgA nephropathy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in mRNA | Whole blood samples will be collected from all subjects for the analysis of mRNA expression of genes relevant to lupus nephritis (IFNa signature, TNFa/TNFa receptor families, defensins, TH1, TH17 related pathway genes. | Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 |
| Change in Proteinuria | Urine (12-hour collections) will be obtained from all subjects in the study for the analysis of proteins relevant to lupus nephritis. | Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 |
| Change in Creatinine | Serum will be collected from all subjects in the study for the analysis of proteins relevant to lupus nephritis. | Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 |
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Inclusion Criteria:
Adults between 18 and 80 years of age, inclusive
Diagnosis of SLE by ACR criteria and biopsy-proven ISN/RPS Class III or IV lupus glomerulonephritis within 2 years
Persistently active nephritis defined as proteinuria greater than or equal to 1.0 g/day for 3 months or more, AND at least 1 of the following:
Stable dose of ACE inhibitor/ARB for 4 weeks prior to study enrollment, unless previously intolerant to or having a contraindication to ACE inhibitors and ARBs
If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 15 mg/day of prednisone for at least 4 weeks prior to study enrollment. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 4 weeks prior study enrollment.
Clarification of inclusion criteria for controls: Any patient with an idiopathic glomerular disease who does not have lupus nephritis. This includes patients with minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis, and IgA nephropathy.
Exclusion Criteria:
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Approximately 50 adult patients, 25 with lupus nephritis 25 control patients who have greater than 1 gram per day proteinuria and non-SLE diagnoses, and who qualify for this study based upon the stated inclusion/exclusion criteria will be recruited from the Glomerular Center at Columbia University Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Appel, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center, Division of Nephrology, Glomerular Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |