New Data Boosts Value Proposition of AlloSure

When our kidneys fail to function as they should, our treatment options generally begin with dialysis and end with a kidney transplant. Unfortunately, transplanted kidneys last, on average, between 12 years and 15 years (depending on if the donor is living or deceased, and if they are a relative or not). Some recipients are lucky if they even get five good years out of their transplanted kidney. CareDx has already established the clinical value of AlloSure, a donor-derived cell-free DNA test designed to assess allograft health in kidney transplant patients, and new data demonstrates the test's clinical utility in patients who require repeat kidney transplants. The findings, published in the American Journal of Transplantation in December, could go a long way toward filling an unmet need in the space by helping doctors closely monitor and optimize care for this particular population. "The relevance of this paper is we've demonstrated for the first time how [the test] actually performs in these patients who have a second or even third or fourth transplant," CareDx Chief Medical Officer Jim Yee told MD+DI. Yee explained that most of the time when a patient receives a new kidney, their failed kidney is left in the body. He said 15% of transplant patients have more than one transplanted kidney in their body. Brisbane, CA-based CareDx initiated the study to find out how its AlloSure test performs for those patients.Â&n...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news

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Kidney transplantation (KT) is the treatment of choice for end stage kidney disease , offering the highest survival benefit amongst all the different renal replacement therapies1. Long term renal allograft and patient survival have shown substantial improvements over time: however, death with a functioning allograft remains the leading cause of late allograft loss with cardiovascular disease (CVD) related deaths representing a major cause of mortality2. While recipients of kidney transplants have lower risk for CVD when compared to the 10-20 fold increased risk in patients with dialysis, their risk of CVD is substantially ...
Source: Kidney International - Category: Urology & Nephrology Authors: Tags: Policy Forum Source Type: research
Abstract BACKGROUND: In chronic kidney disease (CKD), intensive systolic blood pressure (SBP) control reduces mortality at a cost of greater acute kidney injury (AKI) risk. Kidney transplantation involves implantation of denervated kidneys and immunosuppressive medications that increase AKI risk. The optimal blood pressure (BP) target in kidney transplant recipients (KTRs) is uncertain. Prior observational studies from the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) trial demonstrate associations of lower SBP levels and reduced mortality risk, but the relationship of BP with kidney allog...
Source: American Journal of Hypertension - Category: Cardiology Authors: Tags: Am J Hypertens Source Type: research
Delayed allograft function (DGF) is defined as dialysis treatment in the kidney transplant recipient in the first week following transplantation. With the demand for kidney transplants growing and the supply limited, as well as implementation of a national allocation scheme for deceased donor kidneys, rates of DGF remain high, on average, 30% for recipients of deceased donor kidneys. DGF is associated with inferior allograft outcomes, and there are no FDA-approved therapies to mitigate this disorder. There is renewed interest in this therapeutic arena, and there are several recent clinical trials that have considered inter...
Source: Nephron - Category: Urology & Nephrology Source Type: research
AbstractThe complement system is one of the crucial pathophysiological mechanisms that directly influence the function of a transplanted kidney. Since the complement pathways ’ activation potential can be easily determined via their functional activity measurement, we focused on fluctuation in the cascade activity in the early post-transplant period. The aim of the study was to relate the kidney transplantation-induced complement system response to allograft outcome. F orty-two kidney recipients (aged: 53.5 [37–52], 17 females/25 males) and 24 healthy controls (aged: 40.5 [34–51], 13 females/11 males) wer...
Source: Archivum Immunologiae et Therapiae Experimentalis - Category: Allergy & Immunology Source Type: research
Publication date: Available online 15 March 2019Source: The Annals of Thoracic SurgeryAuthor(s): Alan S. Chou, Andreas Habertheuer, Amanda L. Chin, Ibrahim Sultan, Prashanth VallabhajosyulaAbstractBackgroundPrior single-center studies suggest kidney and liver allografts are immunoprotective toward transplanted hearts. The broader effects of simultaneous transplantation of kidney or liver on protection from rejection are unclear.MethodsThe United Network for Organ Sharing database for heart transplantation was queried from 1987 to 2015 and stratified into patients undergoing heart-liver (HLT; n=192), heart-kidney (HKT; n=11...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
CONCLUSIONS: This study demonstrated the efficacy of well-preserved acellular scaffold and vasculature network in post renal transplant outcome in a sheep model. These results have potential to pave the road for further investigations in acellular whole organ transplantation. PMID: 30813040 [PubMed - in process]
Source: Biol Sci Space - Category: Science Authors: Tags: Mater Sci Eng C Mater Biol Appl Source Type: research
AbstractDespite the advances in renal transplantation over the last decades, chronic allograft dysfunction remains the largest concern for patients, their families, clinicians and other members of the multi-disciplinary team. Although we have made progress in improving patient and renal allograft survival within the first year after transplantation, the rate of transplant failure with requirement for commencement of dialysis or re-transplantation has essentially remained unchanged. It is important that paediatric and adult nephrologists and transplant surgeons, not only manage their patients and their renal transplants but...
Source: Pediatric Nephrology - Category: Urology & Nephrology Source Type: research
Abstract BACKGROUND The permissible extent of pretransplant dialysis for patient and allograft survival is unclear. We assumed that a short period of dialysis before living donor kidney transplantation (LDKT) will show the similar results as preemptive kidney transplantation (PKT). MATERIAL AND METHODS We retrospectively evaluated the outcomes of LDKT according to pretransplant dialysis duration in both unmatched cohorts (n=1984) and propensity-score-matched cohorts (n=986) cohorts. The primary study endpoint was post-transplantation patient survival and death-censored graft survival (DCGS) according to the durati...
Source: Annals of Transplantation - Category: Transplant Surgery Authors: Tags: Ann Transplant Source Type: research
Background Prolonged duration of delayed graft function (DGF) may be associated with adverse allograft outcomes, but the association between threshold duration of DGF, acute rejection and long-term allograft loss remains undefined. We aimed to determine the impact of DGF duration on allograft outcomes and to assess whether this association was mediated by acute rejection. Methods Using data from the Australian and New Zealand Dialysis and Transplant Registry, Cox proportional modeling was used to determine the association between quartiles of DGF duration, acute rejection at 6 months and death-censored graft loss (DCG...
Source: Transplantation - Category: Transplant Surgery Tags: Original Clinical Science—General Source Type: research
Conclusions All patients with transplant-associated thrombotic microangiopathy should be screened for the causes of CD. C5 inhibition with eculizumab is an important therapeutic resource to manage this complication. When KTx is necessary, immunosuppression can be safely withhold in case of same donor for both grafts and documented full chimerism.
Source: Transplantation - Category: Transplant Surgery Tags: Original Clinical Science—General Source Type: research
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