NCT03140514 - Urine CXCL10 Chemokine Monitoring Post-renal Transplant | Crick | Crick

Urine CXCL10 Chemokine Monitoring Post-renal Transplant

N/ACompletedNCT03140514

University Hospital, Basel, Switzerland241 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

241

Conditions

Renal Transplant Rejection

Interventions

Rejection treatment according to clinical standard-of-careDRUG

Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel, Transplantation Immunology & Nephrology

Basel, Switzerland

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: First year post-transplant

Secondary Outcomes

Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg)

Microvascular inflammation at 1-year (ptc, g, c4d, cg)

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.