VIRTUUS Children's Study
VIRTUUS
Validating Injury to Renal Transplant Using Urinary Signatures in Children
2 other identifiers
observational
445
2 countries
13
Brief Summary
The objective of the VIRTUUS Children's Study is to adapt identified and validated adult noninvasive diagnostic and prognostic biomarkers for the characterization of allograft status in pediatric recipients of kidney allografts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2017
CompletedFirst Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedDecember 12, 2025
December 1, 2025
6.8 years
July 13, 2018
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Amount of CD3E mRNA (CD3-epsilon polypeptide)
The amount of mRNA observed in urinary sample biopsy.
48 months
Amount of CXCL10 (chemokine C-X-C motif ligand 10)
The amount of mRNA observed in urinary sample biopsy.
48 months
Amount of 18s rRNA
The amount of mRNA observed in urinary sample biopsy.
48 months
Eligibility Criteria
Subjects 2 to 18 years of age meeting inclusion criteria will be recruited from the participating sites' Nephrology outpatient clinics or inpatient settings. All sites may choose to enroll Spanish speaking subjects pending the site has necessary resources to translate/interpret study related information. Sites choosing to enroll Spanish speaking subjects will have a native speaking translator or interpreter available to prevent any miscommunication during the consent process.
You may qualify if:
- Males or females between 2 to 18 years at the time of recruitment
- Receiving the first, or additional, incident kidney transplants.
- Have an existing/prevalent transplant with a scheduled kidney allograft biopsy.
- Parental/guardian permission (informed consent) and, if appropriate, child assent.
You may not qualify if:
- Patient's primary medical team feels the subject's participation is not safe.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of California-San Diego, Rady Children's Hospital
La Jolla, California, 92093-0894, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
University of California
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94304, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-291, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Joan & Sanford I. Weill Medical College of Cornelle University
New York, New York, 10065-4805, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
CHOP
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Vancouver Children's Hospital
Vancouver, British Columbia, V6T 1Z3, Canada
Related Publications (1)
Ettenger RB, Seifert ME, Blydt-Hansen T, Briscoe DM, Holman J, Weng PL, Srivastava R, Fleming J, Malekzadeh M, Pearl M. Detection of Subclinical Rejection in Pediatric Kidney Transplantation: Current and Future Practices. Pediatr Transplant. 2024 Sep;28(6):e14836. doi: 10.1111/petr.14836.
PMID: 39147695DERIVED
Biospecimen
Blood, sputum, urine, tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brendan Keating, DPhil
Children's Hospital of Philadelphia and Hospital of The University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2018
First Posted
October 25, 2018
Study Start
August 10, 2017
Primary Completion
May 31, 2024
Study Completion
March 31, 2026
Last Updated
December 12, 2025
Record last verified: 2025-12