Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01470183|
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : February 7, 2014
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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Observational Model:||Case Control|
|Official Title:||Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients|
|Study Start Date :||October 2011|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
Lupus Nephritis 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470183
|United States, New York|
|Columbia University Medical Center, Division of Nephrology, Glomerular Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Gerald Appel, MD||Columbia University|