Urine CXCL10 Chemokine Monitoring Post-renal Transplant

In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.

Study Overview

• Status: Completed
• Conditions: Renal Transplant Rejection
• Intervention / Treatment: Drug: Rejection treatment according to clinical standard-of-care

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Transplantation Immunology & Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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	Drug: Rejection treatment according to clinical standard-of-care; Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection
No Intervention: Control; Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant, but the values are concealed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Graft and its cause	Long-term outcome Graft and its cause	yearly up to 10 years
Death and its cause	Long-term outcome Death and its cause	yearly up to 10 years
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
Proteinuria	Long-term outcome Proteinuria	yearly up to 10 years
Biopsy-proven rejection	Long-term outcome Biopsy-proven rejection	yearly up to 10 years

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Stefan Schaub, MD, MSc, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Urine chemokine monitoring
• Other Study ID Numbers: Urine chemokine monitoring

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No