Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Centocor Research & Development, Inc.
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01156428
First received: July 1, 2010
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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
Proteinuria
Kidney Injury
Chronic Kidney Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Rogosin Institute:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Whole blood, serum, urine, kidney tissue


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156428

Locations
United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Sponsors and Collaborators
The Rogosin Institute
Centocor Research & Development, Inc.
Investigators
Principal Investigator: Alan Perlman, MD The Rogosin Institute
  More Information

No publications provided

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01156428     History of Changes
Other Study ID Numbers: 0908010598
Study First Received: July 1, 2010
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Rogosin Institute:
Nephritic syndrome
Nephrotic syndrome
Proteinuria
Acute kidney injury
Chronic kidney disease
Lupus nephritis

Additional relevant MeSH terms:
Kidney Diseases
Nephrotic Syndrome
Proteinuria
Renal Insufficiency, Chronic
Nephrosis
Renal Insufficiency
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 20, 2014