Clinical Trial: Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
Brief Summary:
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
Detailed Summary:
Sponsor: Columbia University
Current Primary Outcome:
- Change in mRNA [ Time Frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 ]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.
- Change in Proteinuria [ Time Frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 ]Urine (12-hour collections) will be obtained from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
- Change in Creatinine [ Time Frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 ]Serum will be collected from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Columbia University
Dates:
Date Received: November 7, 2011
Date Started: October 2011
Date Completion:
Last Updated: February 5, 2014
Last Verified: February 2014