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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03206801
Registration number
NCT03206801
Ethics application status
Date submitted
28/06/2017
Date registered
2/07/2017
Date last updated
1/12/2023
Titles & IDs
Public title
Urine CXCL10 Monitoring Trial in Kidney Transplant
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Scientific title
A Randomized Controlled Trial of Urine CXCL10 Chemokine Monitoring Post-renal Transplant
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Secondary ID [1]
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364003
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Secondary ID [2]
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B2017:076
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant; Complications
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Rejection of Renal Transplant
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Kidney transplant biopsy
Experimental: Intervention - Participants with high urine CXCL10 randomized to the Intervention Arm will undergo a kidney transplant biopsy to check for rejection. Biopsy-proven subclinical rejection will be treated per study protocol.
No Intervention: Control - Participants with high urine CXCL10 randomized to the Control Arm will continue routine post-transplant surveillance with serum creatinine and proteinuria; serial urine samples will continue to be collected and analyzed (blinded), but not used to direct care.
Treatment: Surgery: Kidney transplant biopsy
Elevated urine CXCL10 will trigger a study biopsy in patients randomized to the intervention arm. Subclinical rejection will be treated per protocol.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death-censored graft loss
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Assessment method [1]
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Return to dialysis or re-transplant
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Timepoint [1]
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2 weeks-12 months post-transplant
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Primary outcome [2]
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Clinical indication biopsy-proven acute rejection
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Assessment method [2]
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Clinical rejection, Banff criteria
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Timepoint [2]
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2 weeks-12 months post-transplant
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Primary outcome [3]
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De novo donor specific antibody development
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Assessment method [3]
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De novo human leukocyte antibody (HLA) antibodies, donor specific
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Timepoint [3]
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2 weeks-12 months post-transplant
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Primary outcome [4]
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Subclinical tubulitis
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Assessment method [4]
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Subclinical rejection, Banff criteria
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Timepoint [4]
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12-month study exit biopsy
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Primary outcome [5]
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Interstitial fibrosis and inflammation (IFTA + i)
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Assessment method [5]
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IFTA + i, defined by Mayo criteria
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Timepoint [5]
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12-month study exit biopsy
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Secondary outcome [1]
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Renal allograft function
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Assessment method [1]
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Change in eGFR (slope, ?) and graft function (eGFR) (absolute, mL/min)
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Timepoint [1]
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6, 12, 24 and 60 months post-transplant
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Secondary outcome [2]
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Microvascular inflammation
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Assessment method [2]
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Banff ptc, g, c4d, cg
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Timepoint [2]
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12-month study exit biopsy
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Secondary outcome [3]
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Development IFTA from implantation to 12-months
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Assessment method [3]
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Banff ? ci, ct, cv
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Timepoint [3]
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12-month study exit biopsy
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Secondary outcome [4]
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Days from transplantation to clinical-biopsy proven rejection
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Assessment method [4]
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Time to biopsy proven rejection
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Timepoint [4]
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2 weeks-12 months post-transplant
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Secondary outcome [5]
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Albuminuria >300mg/day
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Assessment method [5]
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Urine albumin: Cr ratio
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Timepoint [5]
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6, 12, 24 and 60 months post-transplant
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Secondary outcome [6]
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Cost-effectiveness of urine CXCL10 monitoring strategy
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Assessment method [6]
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Costs of urine CXCL10 screening
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Timepoint [6]
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2 weeks-12 months post-transplant
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Secondary outcome [7]
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Quality of life
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Assessment method [7]
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EuroQOL (EQ-5DL)
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Timepoint [7]
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6 and 12 months post-transplant
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Secondary outcome [8]
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Urine CXCL10 kinetics
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Assessment method [8]
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Change in urine CXCL10 levels in response to rejection therapy
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Timepoint [8]
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2 weeks-12 months post-transplant
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Eligibility
Key inclusion criteria
1. Participants must be able to understand and provide written informed consent
2. Stated willingness to comply with all study procedures and availability for the
duration of the study
3. All ethnic and gender groups will have equal access to the study
4. Incident adult (age =18) renal transplant patients with a living or deceased donor
kidney transplant
5. Confirmed elevated urine CXCL10:Cr without a urinary tract infection or gross
hematuria.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Primary non-function
2. Blood group (ABO) incompatible
3. Pre-transplant donor specific antibody (DSA) positive (MFI>1000 OR positive flow
crossmatch)
4. Human leukocyte (HLA) 0 HLA antigen D-related (DR) + 0 major HLA class 2 (DQ) mismatch
5. Presence of other transplanted organ or co-transplanted organ
6. Medical contraindication to biopsy or rejection treatment
7. Followed outside of investigational center
8. Participation in other interventional trials within 4-weeks post-transplant or anytime
post-transplant till study end at 12-months
9. Intention to not use a maintenance immunosuppression regimen consisting of calcineurin
inhibitor (CNI) and anti-proliferative agents
10. Any condition that, in the opinion of the investigator, would pose risk to the
subject's safe participation, or interfere with their ability to comply with the study
requirements, or may impact the quality of interpretation of the data.
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Study design
Purpose of the study
Screening
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
420
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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Manitoba
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Manitoba
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Canadian National Transplant Research Program
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase II-III multi-center prospective randomized controlled clinical trial of
incident adult renal transplant patients.
The primary objective of this study is to determine if the early treatment of rejection, as
detected by urinary CXCL10, will improve renal allograft outcomes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03206801
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Julie Ho, MD
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Address
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University of Manitoba
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kiran Sran, MSc
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Address
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Country
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Phone
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204-787-3618
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03206801
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