Urine CXCL10 Chemokine Monitoring Post-renal Transplant

Renal Transplant Rejection Clinical Trial

Official title:

Urine CXCL10 Chemokine Monitoring Post-renal Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140514
• Other study ID #: Urine chemokine monitoring
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Renal Transplant Rejection

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