A pilot clinical trial to evaluate the feasibility and acceptability of: A prospective, unblinded, randomized-controlled, multicenter biomarker intervention trial of a urinary CXCL10 clinical surveillance program in pediatric kidney transplant recipients for early ascertainment and treatment of subclinical allograft inflammation and preservation of kidney transplant function.
Kidney transplant rejection remains a major issue for children after kidney transplantation. Please rejection episodes are the primary contributor to premature kidney graft failure. Current clinical monitoring with blood tests like serum creatinine are ineffective to identify early rejection. We have developed and validated a urine test called CXCL10 that effectively identifies inflammation within the transplant and is an early sign acute rejection.
This clinical trial will evaluate with a regular screening with CXCL10 can improved long-term graft function by effectively identifying and treating episodes graft inflammation at an early stage before there is any detectable clinical impact from kidney damage. This study will randomize children who are more than six months after their kidney transplant to either receive the intervention of serial monitoring by urinary CXCL10 or will have samples collected as part of a control group. They will be followed for two years, two ascertain changes in kidney function in that time. The group that is assigned to do serial monitoring will have additional testing if the CXCL10 level is high and will receive treatment based on the additional testing which includes diagnosis of rejection.
This 1st stage of the trial is to conduct a pilot study that will demonstrate the feasibility of the larger, definitive clinical trial. The goals will be to the establish that 1) we can meet a target to enroll and randomize an initial 60 patients from 3 centers to the study; 2) we can execute the logistical aspects of the trial including obtaining samples on time, CXCL10 testing and reporting, and application of the clinical protocol for positive CXCL10 tests; and 3) to determine the most economical approach for testing in the definitive trial.
The findings of this trial will be used to support a subsequent application for a larger, definitive, multicenter clinical trial.
