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
- Renal Transplant
- Renin-Angiotensin System
- Rejection Acute Renal
- Rejection Chronic Renal
- Rejection of Renal Transplant
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Renal Transplantation | Kidney 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.