Renal Transplant Rejection Clinical Trial
Official title:
Urine CXCL10 Chemokine Monitoring Post-renal Transplant
Verified date | August 2022 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.
Status | Completed |
Enrollment | 241 |
Est. completion date | July 15, 2022 |
Est. primary completion date | July 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel, Transplantation Immunology & Nephrology | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Graft and its cause | Long-term outcome Graft and its cause | yearly up to 10 years | |
Secondary | Death and its cause | Long-term outcome Death and its cause | yearly up to 10 years | |
Secondary | 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 | |
Secondary | Proteinuria | Long-term outcome Proteinuria | yearly up to 10 years | |
Secondary | Biopsy-proven rejection | Long-term outcome Biopsy-proven rejection | yearly up to 10 years |
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