Renal Transplant Rejection
Conditions
Keywords
Urine chemokine monitoring
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.
Interventions
DRUGRejection treatment according to clinical standard-of-care
Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft loss not due to death of the patient | First year post-transplant | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 |
| Biopsy-proven clinical acute rejection | 4-weeks up to 1-year post-transplant | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 |
| Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0 | First year post-transplant | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 |
| Interstitial fibrosis / tubular atrophy with inflammation (IFTA+i defined by the Mayo Clinic criteria) in 1-year surveillance biopsy | First year post-transplant | 1-year composite outcome consisting of at least one of the primary outcomes 1 to 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant | First year post-transplant | total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant |
| Safety assessed by biopsy-related complications within the first year post-transplant | First year post-transplant | biopsy-related complications within the first year post-transplant biopsy-related complications within the first year post-transplant |
| Safety assessed by immunosuppression-related complications as infections and cancer within the first year post-transplant | First year post-transplant | immunosuppression-related complications as infections and cancer within the first year post-transplant |
| Graft and its cause | yearly up to 10 years | Long-term outcome Graft and its cause |
| Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg) | First year post-transplant | Microvascular inflammation at 1-year (ptc, g, c4d, cg) |
| Allograft function measured by creatinine and eGFR | yearly up to 10 years | Long-term outcome Allograft function measured by creatinine and epidermal growth factor receptor (eGFR) |
| Proteinuria | yearly up to 10 years | Long-term outcome Proteinuria |
| Biopsy-proven rejection | yearly up to 10 years | Long-term outcome Biopsy-proven rejection |
| Death and its cause | yearly up to 10 years | Long-term outcome Death and its cause |
| Efficacy assessed by development of IFTA from implantation to 1-year (∆ ci, ct, cv) | First year post-transplant | Development of IFTA from implantation to 1-year (∆ ci, ct, cv) |
| Efficacy assessed by number of days from transplantation to biopsy-proven clinical acute rejection | First year post-transplant | number of days from transplantation to biopsy-proven clinical acute rejection |
| Efficacy assessed by Proteinuria >500mg/day at 6- and 12-months post-transplant | First year post-transplant | Proteinuria \>500mg/day at 6- and 12-months post-transplant |
Countries
Switzerland
Outcome results
None listed