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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140514
Other study ID # Urine chemokine monitoring
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2017
Est. completion date July 15, 2022

Study information

Verified date August 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rejection treatment according to clinical standard-of-care
Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection

Locations

Country Name City State
Switzerland University Hospital Basel, Transplantation Immunology & Nephrology Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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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