Inflammatory and Immune Profiling of Kidney Tissue Obtained From Patients With Newly Diagnosed Kidney Disease

Sponsor

The Rogosin Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01156428

Collaborator

Janssen Research & Development, LLC (Industry)

119

Enrollment

Location

76.1

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proteinuria Kidney Injury Chronic Kidney Disease

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.

Study Design

Study Type:

Observational

Actual Enrollment :

119 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Control Subjects (normal volunteers) Control kidney 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. In the case of donor transplant kidneys, the renal biopsy will be conducted during the act of living donor nephrectomy and transplantation. In the case of renal mass nephrectomies, representative "normal" tissue will be obtained from the nephrectomized kidney at a site distant from the renal mass.
Renal Disease Subjects Patients who require a renal biopsy based upon clinical indications such as proteinuria, hematuria, acute renal failure (ARF) of unclear etiology, chronic kidney disease of unclear etiology, nephrotic syndrome, nephritic syndrome, suspected lupus nephritis or any other medically warranted indication for a biopsy.

Arm

Intervention/Treatment

Control Subjects (normal volunteers)

Control kidney 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. In the case of donor transplant kidneys, the renal biopsy will be conducted during the act of living donor nephrectomy and transplantation. In the case of renal mass nephrectomies, representative "normal" tissue will be obtained from the nephrectomized kidney at a site distant from the renal mass.

Renal Disease Subjects

Patients who require a renal biopsy based upon clinical indications such as proteinuria, hematuria, acute renal failure (ARF) of unclear etiology, chronic kidney disease of unclear etiology, nephrotic syndrome, nephritic syndrome, suspected lupus nephritis or any other medically warranted indication for a biopsy.

Outcome Measures

Primary Outcome Measures

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. [12 months]
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.

Secondary Outcome Measures

Change over time of serum, whole blood and urine inflammatory and immune mediators. [5 years]
Subjects clinical course and outcome will be followed over five years and related to change over time of serum, whole blood and urine inflammatory and immune mediators. This follow-up analysis may yield markers that correlate with therapeutic response.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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