Chronic kidney disease (CKD) is caused by a progressive deterioration of kidney function due to loss of functional units in the kidneys. Once a large proportion of functional units are lost, the patient reaches end-stage renal disease (ESRD). The only option for treating patients with ESRD is dialysis, which is a procedure that is undertaken while the patient awaits a new kidney from a matching donor. The availability of donor kidneys from either living or deceased donors is scarce, and patients often wait for years before a matching donor is found.


How many require a kidney transplant?
In Europe different transplant waiting lists exist such as Eurotransplant, ScanTx and more. In 2016, 10,901 patients in Eurotransplant and 2,027 patients in ScanTx were on the waiting list. The scarce number of available donor kidneys leads to long waiting lines, and around half of the patients are on waiting list for 2-4 years, while a third of patients are on the waiting list for 5 or more years. Based on data from 2019, 71320 kidney transplants were performed in the regions: America, Europe, Africa, Eastern Mediterranean and the Western Pacific.


How are recipients and donors matched?
The identification of potential recipients for a donor kidney involves common elements including blood type, length of time on the waiting list, whether the recipient is a child, whether the body sizes of the donor and recipient are a good match, and severity of the patient’s medical condition. Other factors used to match kidneys include a negative lymphocytotoxic crossmatch, the number of HLA antigens in common between the donor and the recipient based on tissue typing and that the patient has no current infection. When matching organs from deceased donors to patients on the waiting list, many of the factors taken into consideration are the same for all organs.

How are patients receiving a kidney transplantation treated?
Patients receiving a kidney transplant are treated with immunosuppressive treatments (anti-rejection medications). Immunosuppressive treatment of transplant recipients always comes at risk for over-immunosuppression, which has been shown to increase the risk of infections and malignancies, and thus mortality in patients.

Antirejection medications after kidney transplantation include:

The careful evaluation of kidney transplant recipients is important for a successful transplant outcome. With the advances in treatment, most allografts are no longer lost due to acute rejection of the allograft by the kidney transplant recipient. The incidence of acute rejection within the first year following transplantation has declined substantially over the years and is currently between 7-10%. However, due to other factors such as the underlying cause of ESRD and immune mediated injury, early allograft fibrosis is very common. This is evident from studies showing that tubulointerstitial fibrosis and tubular atrophy was detectable in 40% of patients within 6 months, increasing to 65% of recipients within 2 years. Kidney transplantation is therefore not a long-term solution, and transplanted patients have on average 10-15 years before reaching ESRD again. At this point, patients will again commence renal replacement therapy (including dialysis) and return to the transplant wait list. Furthermore, studies have shown that the donor kidney from the second transplantation has a significantly lower survival compared to the first graft. This highlights the necessity for new ways to improve the recipient-donor matching in regards to kidney transplantation, or the development of new effective treatments which either ameliorate the underlying cause of ESRD or directly inhibit the processes that ultimately destroy the functional units of the kidneys.

Previous meta-analysis studies showed that risk prediction models for graft failure mainly include recipient age, gender and comorbidities. Whereas clinical parameters are largely used for the evaluation of kidney transplant recipients, validated biomarkers are lacking. As kidney fibrosis is a strong independent predictor of future loss of kidney function, the evaluation of the fibrotic activity and burden in the recipient might aid the clinician in decisions regarding the therapeutic plan, as well as be used to assess the effect of potential anti-fibrotic treatments.

Rasmussen et al Scientific Reports, 2017

There is an urgent need for improved characterization of kidney transplant recipients as neither clinical parameters nor biomarkers are currently available to accurately predict immediate and long-term kidney function after transplantation. Preliminary findings indicate that the PRO-C6 marker has the potential to close that gap.

The goal of the PRO-C6-Rec project (Link) is to develop a disruptive in vitro diagnostic device (IVD) that may improve the allocation of a scarce pool of donor kidney grafts to suitable recipients. In the project we will investigate how PRO-C6 is associated with different aspects in transplantation, such as histological alterations and oucome. A successful project may lead to a tool that reduces the number of patients returning to the transplant wait list (See Figure 2). The project will generate a non-invasive IVD measuring type VI collagen formation, called the PRO-C6 Test, which has passed technical requirement expectations equivalent to a CE marking. If successful, the PRO-C6 test will be able to reflect the state of the transplant over time, as well as predict rejection and other adverse outcomes.

Why is the project carried out?

The PRO-C6-Rec project investigates the potential clinical utility of the PRO-C6 Test. The project investigates different aspects such as the histological association of PRO-C6 with fibrosis and inflammation in biopsies from clinical centers in the Netherlands and France (See Figure 3). Specifically, the project investigates:

- The association of PRO-C6 with:

  • disease progression and adverse outcomes
  • markers of pathology
  • disease severity

- How treatment impacts PRO-C6 levels in kidney transplant recipients

- How PRO-C6 levels change over time


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