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Renal Transplant Injury and the Renin-Angiotensin System in Kids (RETASK) (RETASK)

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: NCT03317925
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
In pediatric kidney transplant patients, rejection, medication toxicity and ischemia cause early and chronic renal allograft injury, which reduces graft lifespan and patient survival. Early detection of injury would facilitate prevention and treatment. The gold standard surveillance biopsy has limitations including delayed discovery of injury. No noninvasive test identifies graft injury before it is clinically apparent. This project's goal is to develop a novel early marker of subclinical graft injury to facilitate prompt recognition and treatment.

Condition or disease Intervention/treatment
Renal Transplant Renin-Angiotensin System Rejection Acute Renal Rejection Chronic Renal Rejection of Renal Transplant Procedure: Renal Transplantation

Detailed Description:
Kidney damage activates the traditional renin-angiotensin (Ang) system (RAS), characterized by Ang-converting enzyme (ACE)/Ang II/Ang II type 1 receptor. The Ang-converting enzyme 2 (ACE2)/Ang-(1-7)/Mas pathway counteracts this damage. The balance, or ratio, between levels of the ACE/Ang II and ACE2/Ang-(1-7) pathways may be clinically important because Ang-(1-7) counteracts Ang II-mediated injury. An increase in ACE and Ang II expression and a decrease in ACE2 and Ang-(1-7) expression on tubular cells may promote renal injury. Tubular damage may increase urinary loss of protective ACE2 and Ang-(1-7), propagating renal damage by allowing ACE and Ang II to stimulate inflammation and fibrosis unopposed. The investigators hypothesis is that a shift in the urinary ACE-to-ACE2 and Ang II-to-Ang-(1-7) ratios towards ACE2 and Ang-(1-7) predicts acute graft injury diagnosed on renal biopsy and predicts chronic graft damage on renal biopsy.

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Renal Transplant Injury and the Renin-Angiotensin System in Kids (RETASK)
Actual Study Start Date : July 16, 2014
Actual Primary Completion Date : January 20, 2016
Actual Study Completion Date : April 26, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Renal Transplantation
    Kidney transplantation and biomarkers that can identify injury after transplant.


Primary Outcome Measures :
  1. Acute graft injury [ Time Frame: Within six months after kidney transplant ]
    Renal biopsy-confirmed acute renal allograft injury as determined by a pathologist (binary yes or no)


Secondary Outcome Measures :
  1. Chronic graft damage [ Time Frame: Six months after kidney transplant ]
    Renal biopsy-confirmed chronic renal allograft damage as determined by a quantitative fibrosis pathology stain (percent fibrosis from 0 to 100%)

  2. Renal function [ Time Frame: Within six months after kidney transplant ]
    Glomerular filtration rate by the Schwartz equation (mL/min/1.73 m^2)

  3. Proteinuria [ Time Frame: Within six months after kidney transplant ]
    Urine protein-to-creatinine ratio above 0.2 mg/mg creatinine


Biospecimen Retention:   Samples Without DNA
De-identified urine and plasma specimens.


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is an observational study with a convenience sample of patients recruited from Lucile Packard Children's Hospital kidney transplant evaluation clinic.
Criteria

Inclusion Criteria:

  • Ages 1 - 20 years
  • Actively listed on the transplant list at Lucile Packard Children's Hospital at Stanford and received a renal transplant during the study enrollment period

Exclusion Criteria:

  • Transplanted at a center other than Lucile Packard Children's Hospital at Stanford

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): NCT03317925


Locations
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United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Stanford University
Investigators
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Principal Investigator: Andrew M South, MD MS Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03317925    
Other Study ID Numbers: 00046001
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Pediatric Renal Transplant
Renal Allograft
Angiotensin II
Angiotensin-(1-7)
ACE
ACE2