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