Clinical trial NCT01156428: Inflammatory and Immune Profiling of Kidney Tissue Obtained From Patients With Newly Diagnosed Kidney Disease
Official title: Transcriptional Profiling of Kidney Tissue Obtained From Patients With Newly Identified Proteinuria, Nephrotic Syndrome or Nephritic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proteinuria
Kidney Injury
Chronic Kidney Disease
Keywords: Nephritic syndrome
Nephrotic syndrome
Proteinuria
Acute kidney injury
Chronic kidney disease
Lupus nephritis
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Janssen Research & Development, LLC
First posted: 2010-07-02
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: Change over time of serum, whole blood and urine inflammatory and immune mediators.
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Alan Perlman, MD
role: PRINCIPAL_INVESTIGATOR
References: