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

NCT ID: NCT01156428

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2016-11-30

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.

Conditions

Proteinuria; Kidney Injury; Chronic Kidney Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

The Rogosin Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Perlman, MD

Role: PRINCIPAL_INVESTIGATOR

The Rogosin Institute

Locations

The Rogosin Institute

New York, New York, United States

Countries

United States

Other Identifiers

0908010598

Identifier Type: -

Identifier Source: org_study_id