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Completed

NCT Number: NCT03317925

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

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.

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Key information

Conditions

Renal Transplant Rejection Acute Renal Rejection Chronic Renal Rejection of Renal Transplant Renin-angiotensin System

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal transplantation

Procedure

Kidney transplantation and biomarkers that can identify injury after transplant.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Stanford University

Registry information

Acronym: RETASK

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 23, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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