Clinical trial NCT03140514: Urine CXCL10 Chemokine Monitoring Post-renal Transplant
Official title: Urine CXCL10 Chemokine Monitoring Post-renal Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplant Rejection
Keywords: Urine chemokine monitoring
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Graft loss not due to death of the patient
timeFrame: First year post-transplant
measure: Biopsy-proven clinical acute rejection
timeFrame: 4-weeks up to 1-year post-transplant
measure: Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0
timeFrame: First year post-transplant
measure: Interstitial fibrosis / tubular atrophy with inflammation (IFTA+i defined by the Mayo Clinic criteria) in 1-year surveillance biopsy
timeFrame: First year post-transplant
Secondary outcomes:
measure: Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg)
timeFrame: First year post-transplant
measure: Efficacy assessed by development of IFTA from implantation to 1-year (∆ ci, ct, cv)
timeFrame: First year post-transplant
measure: Efficacy assessed by number of days from transplantation to biopsy-proven clinical acute rejection
timeFrame: First year post-transplant
measure: Efficacy assessed by Proteinuria >500mg/day at 6- and 12-months post-transplant
timeFrame: First year post-transplant
measure: Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant
timeFrame: First year post-transplant
measure: Safety assessed by biopsy-related complications within the first year post-transplant
timeFrame: First year post-transplant
measure: Safety assessed by immunosuppression-related complications as infections and cancer within the first year post-transplant
timeFrame: First year post-transplant
measure: Graft and its cause
timeFrame: yearly up to 10 years
measure: Death and its cause
timeFrame: yearly up to 10 years
measure: Allograft function measured by creatinine and eGFR
timeFrame: yearly up to 10 years
measure: Proteinuria
timeFrame: yearly up to 10 years
measure: Biopsy-proven rejection
timeFrame: yearly up to 10 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Transplantation Immunology & Nephrology
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Stefan Schaub, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: