Developing a non-invasive method for the diagnosis and monitoring of kidney transplant rejection

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Kidney transplantation is the best form of treatment for patients with kidney failure, however transplant recipients are at risk of allograft rejection, because the recipient’s immune system recognises the transplanted organ as foreign. Up to 20% of kidney transplant recipients experience at least one episode of rejection. This remains a major cause of kidney transplant failure. Most episodes of rejection are diagnosed by performing a kidney biopsy on patients who have been found to have abnormalities on their blood test results. However, a significant proportion of patients have rejection despite not having abnormal blood test results. In order to detect these cases of “sub-clinical” rejection, the majority of transplant recipients are subjected to surveillance kidney biopsies at pre-determined time points, even in the absence of any clinical problems. Kidney transplant biopsies are invasive, uncomfortable and carry some risk, but remain the only reliable way of diagnosing rejection, especially sub-clinical rejection. Because surveillance biopsies are only performed at a few predetermined time points it is also possible for subclinical rejection to be present weeks or months before it is detected by such a biopsy or becomes clinically evident. Assessment of the pattern of proteins or protein fragments excreted into the urine of kidney transplant recipients may provide an alternative, non-invasive method of understanding the condition and health of the kidney. If a panel of urinary proteins that changes in the setting of kidney transplant rejection could be identified, it could potentially allow for the detection of patients with or at risk of subclinical rejection, therefore avoiding the need to subject large numbers of patients to surveillance biopsies. It might also allow earlier detection of subclinical rejection meaning that it can be treated with before damage is done to the kidney. This pilot study will be performed in collaboration between the Royal Melbourne Hospital and the Walter and Eliza Hall Institute of Medical Research . Kidney transplant recipients at the Royal Melbourne Hospital will have urine samples prospectively collected at pre-determined time points in the first year post-transplantation. These samples will be analysed at the Advanced Technology and Biology Division at the Walter and Eliza Hall Institute of Medical Research (WEHI). Urine protein patterns will be correlated with outcome data obtained in the course of routine clinical care in order to determine the existence of any patterns that correlate with rejection. Serial samples will be analysed to determine whether identification of these proteins at earlier time points can identify patients who ultimately develop rejection. Whether the lack of expression of these proteins can also identify patients who are not at risk of rejection (therefore not requiring surveillance biopsies will also be analysed.

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