Inflammatory and Immune Profiling of Kidney Tissue Obtained From Patients With Newly Diagnosed Kidney Disease
Condition: Proteinuria; Kidney Injury; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria; Nephrotic Syndrome
Study type: Observational

Summary: 
      This study will evaluate in patients with kidney disease, the role that certain inflammatory
      and immune mediators play in promoting kidney damage. The investigators hypothesize that
      certain mediators, (identified in the serum, urine and renal biopsy tissue), of patients with
      a variety of different renal disease states will provide information regarding their clinical
      course and that inflammatory and immune patterns in the serum and urine of patients with
      kidney disease may yield predictive diagnostic information in place of a renal biopsy. The
      ability to detect and quantify these mediators may lead to earlier detection and treatment of
      kidney disease in order to prevent kidney failure and the requirement for renal replacement.

      The study will evaluate serum, blood and urine collected over a one year period post kidney
      biopsy for the presence of inflammatory or immune mediators, which will be correlated with
      kidney pathology findings (gene signatures). These gene signatures will be compared to
      "normal" control specimens obtained from donor transplant kidneys or from normal kidney
      tissue obtained from patients who require their entire kidney removed for a tumor.
    

Detailed description: 
      The aim of the study is to evaluate in humans inflammatory and immune mediators that may play
      a role in kidney damage. The investigators hypothesize that certain inflammatory and immune
      mediators identified in the serum and/or urine of patients with a variety of different renal
      disease states will provide prognostic information regarding their clinical course.
      Furthermore, we hypothesize that RNA transcriptional profiling of renal biopsy specimens will
      identify gene array patterns that provide prognostic information for various disease states.
      Lastly, we hypothesize that patterns of inflammatory and immune mediators identified in serum
      and/or urine may yield predictive diagnostic information in lieu of renal biopsy. The ability
      to detect and quantify these mediators may lead to earlier detection and treatment prior to
      the progression of Chronic Kidney Disease (CKD) to stage 4 and/or 5.

      The study will evaluate serially collected serum, blood and urine over a one-year period post
      kidney biopsy for both the presence of inflammatory or immune mediators. The blood, serum and
      urine inflammatory and immune mediators will be correlated with the kidney pathology gene
      signature. Note that all of the biopsies are conducted based upon clinical indication and not
      for the purpose of the study.

      Renal pathology gene signatures obtained from study subjects will be compared to "normal"
      control specimens. Normal specimens will be obtained from donor transplant kidneys or
      nephrectomy specimens performed on patients undergoing nephrectomy for the clinical
      indication of an identified renal mass. Representative "normal" tissue will be obtained from
      the nephrectomized kidney at a site distant from the renal mass.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject with pre-existing clinical indication for a kidney biopsy including, but not
        limited to, nephritic syndrome, nephritic syndrome or proteinuric disease state.
      
Biospecimen description: 
      Whole blood, serum, urine, kidney tissue
    
Keywords: Nephritic syndrome; Nephrotic syndrome; Proteinuria; Acute kidney injury; Chronic kidney disease; Lupus nephritis