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VIRTUUS Children's Study (VIRTUUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719339
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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

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Study Type : Observational
Estimated Enrollment : 450 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 :
  1. Amount of CD3E mRNA (CD3-epsilon polypeptide) [ Time Frame: 48 months ]
    The amount of mRNA observed in urinary sample biopsy.

  2. Amount of CXCL10 (chemokine C-X-C motif ligand 10) [ Time Frame: 48 months ]
    The amount of mRNA observed in urinary sample biopsy.

  3. 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
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Contact: Sandra Amaral, MD 2644255804 amarals@email.chop.edu
Contact: Janaiya Reason, MPH reasonj@email.chop.edu

Locations
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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: Heather Heather Price    773-755-6368    hprice@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: Emmanuel Edusei       eme2005@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: Janaiya Reason, MPH       reasonj@email.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
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Principal Investigator: Brendan Keating, DPhil Children's Hospital of Philadelphia and Hospital of The University of Pennsylvania
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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 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Children's Hospital of Philadelphia:
Kidney disease
Kidney allograft
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency