Clinical Trials Directory

Trials / Completed

CompletedNCT03317925

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

Status
Completed
Phase
Study type
Observational
Enrollment
29 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
1 Year – 20 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERenal TransplantationKidney transplantation and biomarkers that can identify injury after transplant.

Timeline

Start date
2014-07-16
Primary completion
2016-01-20
Completion
2017-04-26
First posted
2017-10-23
Last updated
2017-11-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03317925. Inclusion in this directory is not an endorsement.