Urine CXCL10 Chemokine Monitoring Post-renal Transplant

Study Overview
=================
Brief Summary
-----------------
In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.

Official Title
-----------------
Urine CXCL10 Chemokine Monitoring Post-renal Transplant

Conditions
-----------------
Renal Transplant Rejection

Intervention / Treatment
-----------------
* Drug: Rejection treatment according to clinical standard-of-care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consenting adult (age>=18) renal allograft recipients Exclusion Criteria: Human Leucocyte Antigen (HLA) -identical living donor transplantation Primary non-function Participation in immunosuppression interventional trials

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant. Sustained elevated levels will trigger performance of a renal allograft biopsy. Any rejection will be treated. Rejection treatment according to clinical standard-of-care | Drug: Rejection treatment according to clinical standard-of-care<br>* Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection<br>|
| No Intervention: Control<br>Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant, but the values are concealed. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft loss not due to death of the patient | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 | First year post-transplant | 
| Biopsy-proven clinical acute rejection | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 | 4-weeks up to 1-year post-transplant | 
| Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0 | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 | First year post-transplant | 
| Interstitial fibrosis / tubular atrophy with inflammation (IFTA+i defined by the Mayo Clinic criteria) in 1-year surveillance biopsy | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 | First year post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg) | Microvascular inflammation at 1-year (ptc, g, c4d, cg) | First year post-transplant | 
| Efficacy assessed by development of IFTA from implantation to 1-year (∆ ci, ct, cv) | Development of IFTA from implantation to 1-year (∆ ci, ct, cv) | First year post-transplant | 
| Efficacy assessed by number of days from transplantation to biopsy-proven clinical acute rejection | number of days from transplantation to biopsy-proven clinical acute rejection | First year post-transplant | 
| Efficacy assessed by Proteinuria >500mg/day at 6- and 12-months post-transplant | Proteinuria >500mg/day at 6- and 12-months post-transplant | First year post-transplant | 
| Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant | total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant | First year post-transplant | 
| Safety assessed by biopsy-related complications within the first year post-transplant | biopsy-related complications within the first year post-transplant biopsy-related complications within the first year post-transplant | First year post-transplant | 
| Safety assessed by immunosuppression-related complications as infections and cancer within the first year post-transplant | immunosuppression-related complications as infections and cancer within the first year post-transplant | First year post-transplant | 
| Graft and its cause | Long-term outcome Graft and its cause | yearly up to 10 years | 
| Death and its cause | Long-term outcome Death and its cause | yearly up to 10 years | 
| Allograft function measured by creatinine and eGFR | Long-term outcome Allograft function measured by creatinine and epidermal growth factor receptor (eGFR) | yearly up to 10 years | 
| Proteinuria | Long-term outcome Proteinuria | yearly up to 10 years | 
| Biopsy-proven rejection | Long-term outcome Biopsy-proven rejection | yearly up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urine chemokine monitoring