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Transcriptional Profiling of Kidney Tissue Obtained From Patients With Newly Identified Proteinuria, Nephrotic Syndrome or Nephritic Syndrome


N/A
18 Years
90 Years
Open (Enrolling by invite only)
Both
Proteinuria, Kidney Injury, Chronic Kidney Disease

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Trial Information

Transcriptional Profiling of Kidney Tissue Obtained From Patients With Newly Identified Proteinuria, Nephrotic Syndrome or Nephritic Syndrome


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.


Inclusion Criteria:



- Male and females, 18 years to 90 years old

- Any subject with pre-existing clinical indication of a kidney biopsy including, but
not limited to, nephritic syndrome, nephritic syndrome or proteinuric disease state.
Additionally, kidney transplant donors will be included for purpose of obtaining
control tissue.

- Willing and able to give consent

- Additionally, kidney transplant donors and patients requiring nephrectomy for removal
of renal mass will be included for purpose of obtaining control tissue.

Exclusion Criteria:

- Subjects on longstanding immunosuppressive agents (empiric initiation of
glucocorticoid therapy within 48 hours prior to kidney biopsy is acceptable)

- Kidney transplant recipient

- Inability to follow-up for future protocol laboratory evaluation

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

The deviation from the norm of whole blood, serum and urine inflammatory and immune mediators, renal biopsy gene signature patterns in subjects with a variety of biopsy proven renal conditions compared to normal subjects.

Outcome Description:

To determine the deviation from the norm of blood and urine inflammatory and immune mediators in subjects that have undergone renal biopsy for clinical indication with resultant biopsy diagnosed renal conditions. To determine the correlation of serum, whole blood and urine inflammatory and immune mediators with the renal pathologic diagnosis as well as the gene signature of the given pathology.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Alan Perlman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Rogosin Institute

Authority:

United States: Institutional Review Board

Study ID:

0908010598

NCT ID:

NCT01156428

Start Date:

July 2010

Completion Date:

April 2014

Related Keywords:

  • Proteinuria
  • Kidney Injury
  • Chronic Kidney Disease
  • Nephritic syndrome
  • Nephrotic syndrome
  • Proteinuria
  • Acute kidney injury
  • Chronic kidney disease
  • Lupus nephritis
  • Kidney Diseases
  • Nephrotic Syndrome
  • Proteinuria
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic

Name

Location

The Rogosin InstituteNew York, New York  10021