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Urine CXCL10 Monitoring Trial in Kidney Transplant
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.
Study details:
This is a Phase II-III multi-center prospective randomized controlled clinical trial of incident adult renal transplant patients. Patients will be screened for eligibility (n≈485) and n≈420 will be enrolled and undergo post-transplant surveillance with urinary CXCL10. Two hundred and fifty patients deemed at high risk for rejection based on a confirmed elevated urine CXCL10 will undergo 1:1 randomization to the intervention and control arms, stratified by center.
The total study duration is approximately 5 years; and there two main phases - screening and intervention. All eligible, enrolled patients will undergo the Screening Phase (n≈420). Routine urine CXCL10 screening will be done from 2 weeks - 9 months post-transplant.
We have previously shown that urine CXCL10 is elevated in ischemia-reperfusion injury, so screening will commence at 2 weeks (+/- 4 days) to exclude this as a potential confounding factor (60). If patient develops a confirmed elevated urine CXCL10 level and is considered high risk for rejection, they will proceed to Randomization in the Intervention Phase, which can occur anytime between 2 weeks - 9 months post-transplant. Participants in the Intervention Arm will undergo renal biopsy to check for rejection.
Biopsy-proven subclinical rejection will be treated per study protocol. Participants in 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. All randomized participants will undergo a 12-month study exit visit with protocol biopsy to determine primary, secondary and long-term outcomes.
Enrolled patients with persistently low urine CXCL10 and low risk of rejection from 2 weeks - 9 months post-transplant will be considered Off-Study (not randomized). They will undergo a 12-month study exit visit (+/- 7 days) to determine secondary and long-term outcomes.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2018-04-03
Primary completion: 2024-12-31
Study completion finish: 2025-12-31
Study type
SCREENING
Phase
PHASE2
PHASE3
Trial ID
NCT03206801
Intervention or treatment
PROCEDURE: Kidney transplant biopsy
Conditions
- • Kidney Transplant; Complications
- • Rejection of Renal Transplant
Find a site
Closest Location:
Royal Adelaide Hospital
Research sites nearby
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Royal Adelaide Hospital
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Intervention
| PROCEDURE: Kidney transplant biopsy
|
NO_INTERVENTION: Control
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Death-censored graft loss | Return to dialysis or re-transplant | 2 weeks-12 months post-transplant |
Clinical indication biopsy-proven acute rejection | Clinical rejection, Banff criteria | 2 weeks-12 months post-transplant |
De novo donor specific antibody development | De novo human leukocyte antibody (HLA) antibodies, donor specific | 2 weeks-12 months post-transplant |
Subclinical tubulitis | Subclinical rejection, Banff criteria | 12-month study exit biopsy |
Interstitial fibrosis and inflammation (IFTA + i) | IFTA + i, defined by Mayo criteria | 12-month study exit biopsy |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Renal allograft function | Change in eGFR (slope, ∆) and graft function (eGFR) (absolute, mL/min) | 6, 12, 24 and 60 months post-transplant |
Microvascular inflammation | Banff ptc, g, c4d, cg | 12-month study exit biopsy |
Development IFTA from implantation to 12-months | Banff ∆ ci, ct, cv | 12-month study exit biopsy |
Days from transplantation to clinical-biopsy proven rejection | Time to biopsy proven rejection | 2 weeks-12 months post-transplant |
Albuminuria >300mg/day | Urine albumin: Cr ratio | 6, 12, 24 and 60 months post-transplant |
Cost-effectiveness of urine CXCL10 monitoring strategy | Costs of urine CXCL10 screening | 2 weeks-12 months post-transplant |
Quality of life | EuroQOL (EQ-5DL) | 6 and 12 months post-transplant |
Urine CXCL10 kinetics | Change in urine CXCL10 levels in response to rejection therapy | 2 weeks-12 months post-transplant |
Frequently Asked Questions
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