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Role of Nox2 in CNI-induced Renal Fibrosis (Nox2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01674465
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

Calcineurin Inhibitors (CNI) are drugs used to suppress the immune system when a person has a solid organ transplant. Although these drugs keep the transplanted organ from being rejected they are toxic to kidneys, or nephrotoxic. CNIs cause damage, called fibrosis, to kidneys.

Fibrosis is a type of scarring that occurs in kidney tissue. Fibrosis can eventually lead to kidney failure. One of the pathways that cause fibrosis is a chronic lack of oxygen to the kidney tissue called "hypoxia". There is a protein called Nox2 that may be involved in how this hypoxia happens in the kidney. The Department of Medicine-Nephrology at the University of Wisconsin is conducting a research study to see how much of the Nox2 protein is present in kidneys that may have fibrosis caused by CNIs and whether a certain type of Magnetic Resonance Imaging (MRI) can be used to tell in advance if the disease caused by CNIs is getting worse. Study hypothesis: MRI, a non-invasive technique, can be used to determine whether CNI induced kidney disease is getting worse. Additionally, the study aims to determine the role of Nox2 in CNI nephrotoxicity.


Condition or disease Intervention/treatment
Kidney Disease Biological: Hypoxyprobe-1

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Role of Nox2 in CNI-Induced Renal Fibrosis
Actual Study Start Date : November 30, 2012
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
CNI-induced nephrotoxicity
Hypoxyprobe-1
Biological: Hypoxyprobe-1
Hypoxyprobe-1 is a biological marker used to detect oxygen levels in tissue;subjects will receive and intravenous solution for 20 minutes containing 500mg/m^2 two-three hours prior to their standard of care biopsy
Other Name: Pimonidazole




Primary Outcome Measures :
  1. Nox2 presence in CNI nephrotoxic kidneys [ Time Frame: two hours post Hypoxyprobe-1 Infusion ]
    The Nox2 protein will be determined in subjects who are potentially have CNI nephrotoxicity


Secondary Outcome Measures :
  1. Oxygenation changes in kidneys using BOLD-MRI. [ Time Frame: 12 months ]
    12 months after a baseline BOLDMRI, subjects will have a second BOLD MRI in order to determine whether there is increased oxygenation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be chosen from non-kidney transplant patients scheduled for a standard of care kidney biopsy.
Criteria

Inclusion Criteria:

  • liver, heart, lung or pancreas transplant recipients
  • suspected CNI induced nephrotoxicity

Exclusion Criteria:

  • minors
  • pregnant women
  • prisoners
  • institutionalized individuals or other vulnerable groups
  • history of allergic reactions or adverse reactions to Pimonidazole
  • Claustrophobia
  • hazardous metallic implants
  • cardiac pacemakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674465


Locations
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United States, Wisconsin
Wisconsin Institute for Medical Research (WIMR)
Madison, Wisconsin, United States, 53705
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Arjang Djamali, MD,MS,FASN University of Wisconsin-Madison, School of Medicine and Public Health, Department of Medicine, Division of Nephrology
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01674465    
Other Study ID Numbers: 2016-0384
R01DK092454 ( U.S. NIH Grant/Contract )
2011-0127 ( Other Identifier: Institution IRB )
A534280 ( Other Identifier: UW Madison )
SMPH/MEDICINE/MEDICINE*N ( Other Identifier: UW Madison )
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Keywords provided by University of Wisconsin, Madison:
Kidney fibrosis
Kidney hypoxia
Calcineurin inhibitors
Additional relevant MeSH terms:
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Kidney Diseases
Fibrosis
Pathologic Processes
Urologic Diseases