Short summary

The objective of this study is to improve long-term kidney graft survival, lower patient morbidity and mortality by use of new genomic, transcriptomic and proteomic biomarkers. This approach should predict the immunological risk profile for the individual transplant recipient, followed by a more tailored pre- and post-transplant immunosuppressive treatment.

Rationale

Renal transplantation is worldwide the choice of treatment for end stage renal disease, due to significantly reduced morbidity and mortality. In Denmark 263 patient had a renal transplantation in 2016 and more than 500 patients are waiting for a kidney. In 2016 twenty patients died on the waiting list and 29 patients were permanently withdrawn.

Today the used "biomarkers" in everyday clinic, are plasma creatinine reflecting the glomerular filtration rate and proteinuria indicating damage to the glomerular filtration barrier. The current gold standard for examination of graft dysfunction is a renal biopsy, with the disadvantage of being an invasive procedure.

By using a standard immunosuppressive protocol a "one-size-fits-all" approach, a substantially proportion of transplant recipients experience over- and under immunosuppression, which leads to either increased risk of malignancy and infection or rejection and graft loss. Subclinical rejection is not detected by current standard measurements. Several studies support that subclinical rejection leads to graft injury, fibrosis and eventually graft loss. Today average kidney graft survival is 15 years, and vital for longer graft survival is early identification of kidney graft injury, resulting in appropriate intervention. Recently the discovery of new biomarkers using molecular diagnostics offer the potential for patient-specific customization of immunosuppressive medication

We will collect urine and blood samples from living donors and from recipient throughout the first year after transplantation and compare potential biomarkers with the clinical status of the recipients.

Description of the cohort

Our cohort consists of patients, adults as well as children, having a renal transplantation either with a deceased donor kidney or a living donor kidney. We aim to include all recipients of kidney transplants and donors.

Data and biological material

We collect urine- and blood samples from patients planned for transplantation. First sample drawn before transplantation, thereafter day 7, 28, 90, 180, 360 and yearly for recipients.

Donors' urine and blood are sampled before donation, day 7 and 360.

We collect thorough baseline characteristics of our research population and clinical information as well as information from the routine blood samples taken during outpatient clinic visits.

Collaborating researchers and departments

Department of Nephrology, Odense University Hospital

• Helle Thiesson, PhD
• Ann-Maria Gramkow

Department of Vascular Surgery, Odense University Hospital

Department of Clinical Immunology, Odense University Hospital

Department of Urology, Odense University Hospital

Department of Pathology, Odense University Hospital

Department of Clinical Genetic, Odense University Hospital