VIRTUUS Children's Study (VIRTUUS)
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| ClinicalTrials.gov Identifier: NCT03719339 |
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Recruitment Status :
Recruiting
First Posted : October 25, 2018
Last Update Posted : September 14, 2021
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Sponsor:
Children's Hospital of Philadelphia
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
- Study Details
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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.
| Condition or disease |
|---|
| Renal Transplant Rejection Pediatric Kidney Disease End Stage Renal Disease Nephropathy BK Virus (Nephropathy) Antibody-mediated Rejection Acute Cellular Graft Rejection |
Show detailed description
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Validating Injury to Renal Transplant Using Urinary Signatures in Children |
| Actual Study Start Date : | August 10, 2017 |
| Estimated Primary Completion Date : | May 31, 2022 |
| Estimated Study Completion Date : | April 30, 2023 |
Primary Outcome Measures :
- Amount of CD3E mRNA (CD3-epsilon polypeptide) [ Time Frame: 48 months ]The amount of mRNA observed in urinary sample biopsy.
- Amount of CXCL10 (chemokine C-X-C motif ligand 10) [ Time Frame: 48 months ]The amount of mRNA observed in urinary sample biopsy.
- Amount of 18s rRNA [ Time Frame: 48 months ]The amount of mRNA observed in urinary sample biopsy.
Biospecimen Retention: Samples With DNA
Blood, sputum, urine, tissue
Information from the National Library of Medicine
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| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Patient's primary medical team feels the subject's participation is not safe.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719339
Contacts
| Contact: Sandra Amaral, MD | 2644255804 | amarals@email.chop.edu | |
| Contact: Annie Chung | 267-425-3934 | chunga@chop.edu |
Locations
| United States, California | |
| University of California-San Diego, Rady Children's Hospital | Recruiting |
| La Jolla, California, United States, 92093-0894 | |
| Contact: Elizabeth Inguilli, MD 858-966-8052 eingulli@ucsd.edu | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Rachel Lestz, MD 323-361-1014 rlestz@chla.usc.edu | |
| Contact: Sharon Tang 323-361-1014 shatang@chla.usc.edu | |
| University of California | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Patricia Weng, MD 310-206-6987 PWeng@mednet.ucla.edu | |
| Contact: Barbara Gales 310-206-0799 bgales@mednet.ucla.edu | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Paul Grimm, MD 650-724-0353 pgrimm@stanford.edu | |
| Contact: Suvarna Bhamre 650 521-6072 suvarna@stanford.edu | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-291 | |
| Contact: Asha Moudgil, MD 202-476-5058 AMoudgil@childrensnational.org | |
| Contact: Whitney Osborne 202-476-5488 WOsborne@childrensnational.org | |
| United States, Illinois | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Debora Matossian, MD 312-227-4000 DMatossian@luriechildrens.org | |
| Contact: Stephen Harris 312-227-2876 sharris@luriechildrens.org | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Sarah Kizilbash, MD 612-626-2922 kizil010@umn.edu | |
| Contact: Amy Hanson (612) 626-4424 amhanson@umn.edu | |
| United States, New York | |
| Joan & Sanford I. Weill Medical College of Cornelle University | Recruiting |
| New York, New York, United States, 10065-4805 | |
| Contact: Juhi Kumar, MD 646-962-4324 juk2013@med.cornell.edu | |
| Contact: Gabriel Stryjniak 212-746-2377 gas2014@med.cornell.edu | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: David Hooper, MD 513-803-2114 David.Hooper@cchmc.org | |
| Contact: Bliss Magella bliss.magella@cchmc.org | |
| United States, Pennsylvania | |
| CHOP | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Sandra Amaral, MD 267-425-5804 amarals@email.chop.edu | |
| Contact: Annie Chung 267-425-3934 chung@chop.edu | |
| University of Pennsylvania | Active, not recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Jodi Smith, MD 206-987-2524 jodi.smith@seattlechildrens.org | |
| Contact: Megan Kelton 206-987-5539 megan.kelton@seattlechildrens.org | |
| Canada, British Columbia | |
| Vancouver Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6T 1Z3 | |
| Contact: Tom Blydt-Hansen, MD 604-875-2000 Tom.BlydtHansen@cw.bc.ca | |
| Contact: Candice Wiedman Candice.Wiedman@bcchr.ca | |
Sponsors and Collaborators
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Brendan Keating, DPhil | Children's Hospital of Philadelphia and Hospital of The University of Pennsylvania |
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT03719339 |
| Other Study ID Numbers: |
17-013841 1R01HD091185-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 25, 2018 Key Record Dates |
| Last Update Posted: | September 14, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
Keywords provided by Children's Hospital of Philadelphia:
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Kidney disease Kidney allograft |
Additional relevant MeSH terms:
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Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |