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

NCT03317925 | Completed

• 1 other identifier: 00046001
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant; Renin-Angiotensin System; Rejection Acute Renal; Rejection Chronic Renal; Rejection of Renal Transplant

Keywords

Pediatric Renal Transplant; Renal Allograft; Angiotensin II; Angiotensin-(1-7); ACE; ACE2

Outcome Measures

Primary Outcomes (1)

• Acute graft injury

  Renal biopsy-confirmed acute renal allograft injury as determined by a pathologist (binary yes or no)

  Within six months after kidney transplant

Secondary Outcomes (3)

• Chronic graft damage

  Six months after kidney transplant

• Renal function

  Within six months after kidney transplant

• Proteinuria

  Within six months after kidney transplant

Interventions

Renal Transplantation PROCEDURE

Kidney transplantation and biomarkers that can identify injury after transplant.

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Stanford University: collaborator

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

De-identified urine and plasma specimens.

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Andrew M South, MD MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: July 16, 2014
• Primary Completion: January 20, 2016
• Study Completion: April 26, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)