Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

Study Overview
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Brief Summary
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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: Establish the baseline biomarker characteristics of patients Determine the variability of biomarker measures over time Correlate biomarkers with disease phenotype

Official Title
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Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

Conditions
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Lupus Nephritis

Participation Criteria
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Eligibility Criteria
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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: Hematuria (greater than or equal to 5 RBC/hpf) on 2 or more urinalyses done greater than or equal to 2 weeks apart anti-dsDNA positive or anti-Smith positive, or low C3 or C4 complement level. (d) Stable immunosuppression consisting of mycophenolate mofetil (MMF) 13 g/day with/without corticosteroids up to prednisone equivalent of 15 mg/day, or azathioprine 13 mg/kg/day with/without corticosteroids up to prednisone equivalent of 20 mg/day. 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: B-cell depletion therapy in past 1 yr, or evidence of persistent B cell depletion at the time of screening. Received an investigational drug (including vaccines) or used an investigational medical device within 3 months of study enrollment or within 5 half-lives of agent, whichever is longer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lupus Nephritis Patients<br>Male or female subjects age 18 and older Must have confirmed diagnosis of Class III or Class IV lupus nephritis by biopsy Must have stable disease on medication at time of enrollment | |
| Control Patients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus Nephritis