Overview

This trial is active, not recruiting.

Conditions proteinuria, kidney injury, chronic kidney disease
Sponsor The Rogosin Institute
Collaborator Janssen Research & Development, LLC
Start date July 2010
End date November 2016
Trial size 119 participants
Trial identifier NCT01156428, 0908010598

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
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.

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.
time frame: 12 months

Secondary Outcomes

Measure
Change over time of serum, whole blood and urine inflammatory and immune mediators.
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Transcriptional Profiling of Kidney Tissue Obtained From Patients With Newly Identified Proteinuria, Nephrotic Syndrome or Nephritic Syndrome
Principal investigator Alan Perlman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The Rogosin Institute.