PROACT Pilot Trial

NCT06564649 | Active Not Recruiting

• 1 other identifier: H23-00306
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

Kidney transplantation is considered the best option to treat end-stage kidney disease, but the recipient's immune system may respond with rejection to the transplanted organ, leading to permanent kidney damage and failure. The current standard for rejection monitoring in transplanted recipients is regular blood creatinine testing and kidney biopsies. Creatinine doesn't detect rejection until damages had occurred, causing some amount of kidney failure, and kidney biopsies are only done at set timepoints. A new test called CXCL10 is shown to be more effective in detecting rejection from previous research and can be done as often as needed. Therefore, The investigators are doing this randomized trial to test CXCL10 as part of clinical care and to help design a larger national clinical trial in the future.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Capacity of Recruitment for future definitive trial

  Demonstrate capacity to recruit, randomize and retain 60 participants

  8 months

Secondary Outcomes (2)

• Study Protocol Feasibility

  2 years

• Trial Cost and logistical support evaluation

  2 years

Study Arms (2)

Interventional Group

Participants in the intervention group will have urinary CXCL10 testing done on the Ella Platform up to every month for a 2 year follow up.

Diagnostic Test: CXCL10 Monitoring at clinical frequency

Non-Interventional Group

Participants in the control group will have the standard of care urine test done via the clinical lab.

Interventions

CXCL10 Monitoring at clinical frequency DIAGNOSTIC_TEST

The intervention is the implementation of real-time, serial urinary CXCL10 monitoring, with protocolized further clinical responses in the setting of elevated urinary CXCL10 levels.

Interventional Group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study includes prevalent pediatric kidney transplant recipients who are below 19 years of page at the time of transplant and who are more than 6 months after their transplant.

You may qualify if:

• Prevalent pediatric kidney transplant recipients (\<19 years at transplantation) who are more than 6 months after transplant, with informed consent and assent.
• Must be available to follow-up for two years after initiation of urinary CXCL10 monitoring

You may not qualify if:

• Expected transfer to adult care in the next 2 years.
• In center routine follow-up interval \>3 months between visits
• Non-adherence to routine transplant clinic visits.
• Estimated glomerular filtration rate \<30 ml/min/1.73m2 (stage IV/V CKD).
• Inability to reliably obtain urinary samples for monitoring purposes.
• Contraindication to kidney biopsy.

Sponsors & Collaborators

• University of British Columbia: lead
• University of Toronto: collaborator
• University of Manitoba: collaborator

Study Sites (3)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

The Children's Hospital of Winnipeg

Winnipeg, Manitoba, R3E 3P4, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

Location

Related Publications (12)

• Chua A, Cramer C, Moudgil A, Martz K, Smith J, Blydt-Hansen T, Neu A, Dharnidharka VR; NAPRTCS investigators. Kidney transplant practice patterns and outcome benchmarks over 30 years: The 2018 report of the NAPRTCS. Pediatr Transplant. 2019 Dec;23(8):e13597. doi: 10.1111/petr.13597. Epub 2019 Oct 27.

  PMID: 31657095 BACKGROUND

• Smith JM, Martz K, Blydt-Hansen TD. Pediatric kidney transplant practice patterns and outcome benchmarks, 1987-2010: a report of the North American Pediatric Renal Trials and Collaborative Studies. Pediatr Transplant. 2013 Mar;17(2):149-57. doi: 10.1111/petr.12034. Epub 2013 Jan 2.

  PMID: 23281637 BACKGROUND

• Wiebe C, Gibson IW, Blydt-Hansen TD, Karpinski M, Ho J, Storsley LJ, Goldberg A, Birk PE, Rush DN, Nickerson PW. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012 May;12(5):1157-67. doi: 10.1111/j.1600-6143.2012.04013.x. Epub 2012 Mar 19.

  PMID: 22429309 BACKGROUND

• Dart AB, Schall A, Gibson IW, Blydt-Hansen TD, Birk PE. Patterns of chronic injury in pediatric renal allografts. Transplantation. 2010 Feb 15;89(3):334-40. doi: 10.1097/TP.0b013e3181bc5e49.

  PMID: 20145525 BACKGROUND

• Blydt-Hansen TD, Sharma A, Gibson IW, Mandal R, Wishart DS. Urinary metabolomics for noninvasive detection of borderline and acute T cell-mediated rejection in children after kidney transplantation. Am J Transplant. 2014 Oct;14(10):2339-49. doi: 10.1111/ajt.12837. Epub 2014 Aug 19.

  PMID: 25138024 BACKGROUND

• Birk PE, Stannard KM, Konrad HB, Blydt-Hansen TD, Ogborn MR, Cheang MS, Gartner JG, Gibson IW. Surveillance biopsies are superior to functional studies for the diagnosis of acute and chronic renal allograft pathology in children. Pediatr Transplant. 2004 Feb;8(1):29-38. doi: 10.1046/j.1397-3142.2003.00122.x.

  PMID: 15009838 BACKGROUND

• Landsberg A, Riazy M, Blydt-Hansen TD. Yield and utility of surveillance kidney biopsies in pediatric kidney transplant recipients at various time points post-transplant. Pediatr Transplant. 2021 Mar;25(2):e13869. doi: 10.1111/petr.13869. Epub 2020 Oct 19.

  PMID: 33073499 BACKGROUND

• Blydt-Hansen TD, Gibson IW, Gao A, Dufault B, Ho J. Elevated urinary CXCL10-to-creatinine ratio is associated with subclinical and clinical rejection in pediatric renal transplantation. Transplantation. 2015 Apr;99(4):797-804. doi: 10.1097/TP.0000000000000419.

  PMID: 25222013 BACKGROUND

• Blydt-Hansen TD, Sharma A, Gibson IW, Wiebe C, Sharma AP, Langlois V, Teoh CW, Rush D, Nickerson P, Wishart D, Ho J. Validity and utility of urinary CXCL10/Cr immune monitoring in pediatric kidney transplant recipients. Am J Transplant. 2021 Apr;21(4):1545-1555. doi: 10.1111/ajt.16336. Epub 2020 Oct 30.

  PMID: 33034126 BACKGROUND

• Birk PE, Blydt-Hansen TD, Dart AB, Kaita LM, Proulx C, Taylor G. Low incidence of adverse events in outpatient pediatric renal allograft biopsies. Pediatr Transplant. 2007 Mar;11(2):196-200. doi: 10.1111/j.1399-3046.2006.00659.x.

  PMID: 17300500 BACKGROUND

• Lamarche C, Sharma AK, Goldberg A, Wang L, Blydt-Hansen TD. Biomarker implementation: Evaluation of the decision-making impact of CXCL10 testing in a pediatric cohort. Pediatr Transplant. 2021 May;25(3):e13908. doi: 10.1111/petr.13908. Epub 2020 Nov 6.

  PMID: 33155737 BACKGROUND

• Wiebe C, Gibson IW, Blydt-Hansen TD, Pochinco D, Birk PE, Ho J, Karpinski M, Goldberg A, Storsley L, Rush DN, Nickerson PW. Rates and determinants of progression to graft failure in kidney allograft recipients with de novo donor-specific antibody. Am J Transplant. 2015 Nov;15(11):2921-30. doi: 10.1111/ajt.13347. Epub 2015 Jun 10.

  PMID: 26096305 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples

Study Officials

• Tom BLydt-Hansen, MDCM, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics, Faculty of Medicine, University of British Columbia

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Deidentified participant data will be retained for at least 5 years after primary study reporting to the sponsor has been completed.
• Access Criteria: * Relevant Research Ethics Board Approval * Approval from the principal investigator

Locations

CA (3)