Urine CXCL10 Chemokine Monitoring Post-renal Transplant

Not Applicable

Completed

• Conditions: Renal Transplant Rejection
• Interventions: Drug: Rejection treatment according to clinical standard-of-care

• Registration Number: NCT03140514
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Study Start: 2017-09-28
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Rejection treatment according to clinical standard-of-care	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

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Graft and its cause	yearly up to 10 years	Long-term outcome Graft and its cause
Biopsy-proven rejection	yearly up to 10 years	Long-term outcome Biopsy-proven rejection
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
Proteinuria	yearly up to 10 years	Long-term outcome Proteinuria
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 microvascular inflammation at 1-year (ptc, g, c4d, cg)	First year post-transplant	Microvascular inflammation at 1-year (ptc, g, c4d, cg)
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
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 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
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)
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
Death and its cause	yearly up to 10 years	Long-term outcome Death and its cause

Trial Locations

Locations (1)

University Hospital Basel, Transplantation Immunology & Nephrology; 🇨🇭 Basel, Switzerland