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

NCT01156428 | Completed

• 1 other identifier: 0908010598
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Proteinuria; Kidney Injury; Chronic Kidney Disease

Keywords

Nephritic syndrome; Nephrotic syndrome; Proteinuria; Acute kidney injury; Chronic kidney disease; Lupus nephritis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 months

Secondary Outcomes (1)

• Change over time of serum, whole blood and urine inflammatory and immune mediators.

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Rogosin Institute: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, urine, kidney tissue

MeSH Terms

Conditions

Proteinuria; Renal Insufficiency, Chronic; Nephrotic Syndrome; Acute Kidney Injury; Lupus Nephritis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Nephrosis; Glomerulonephritis; Nephritis; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alan Perlman, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (1)