Short summary

Immunoglobulin A nephropathy (IgAN) is the most common glomerular disease responsible for end-stage renal failure worldwide. Recurrence rate of IgAN after renal transplantation is high. We will perform a retrospective multicenter study and expect the study will provide information regarding potential predictors of recurrent IgAN, which information might extend graft-survival on long term, and ultimately increase quality of life for the patients and decrease further costs.

Rationale

Immunoglobulin A nephropathy (IgAN) is the most common glomerular disease responsible for end-stage renal failure worldwide, and often ends with the need of a kidney transplantation. It is well known that IgAN can recurs in the graft-kidney, and a common cause to graft loss. Previously retrospective studies suggest that immunesuppression protocol with steroids reduced the risk of recurrent IgAN, but the studies are at high risk of selection bias, why more research are mostly warranted. At Aarhus University Hospital (AUH) and Odense University Hospital (OUH) two different standards immunosuppression protocols are used, with respectively without steroid. This provides a unique opportunity to compare the effect of systematic use of steroid-continuation respectively steroid free protocols for kidney transplantation because of IgAN, thus contributing to clarification on the subject.

The main aim is to investigate the risk of recurrent IgAN in renal transplant recipients between steroid continuation versus steroid-free immunosuppression protocols. Sub-aims is to examine potential predictors of recurrence IgAN i.e. donor-type (deceased, living related, living non-related), HLA-mismatch, pathological findings in biopsy and age.

Description of the cohort

All adult patients (age > 18 years) with a kidney-only transplantation from year 1990 to 2020 at Aarhus University Hospital (AUH) or Odense University Hospital (OUH) due to IgAN.

Data and biological material

Data from Danish Nephrological Society national register (DNSL) and patient journals. From the national register: gender, age, comorbidity index, time for ESRD, dialysis-treatment, age at time of transplantation, number and time of transplantation(s), donor type (deceased, living- related, living non-related), cold ischemia-time for each transplantation, and possible death. From patient journals: age at time of diagnosed with IgAN, verification of IgAN, biopsy-findings in native kidney, HLA-mismatch, accumulated prednisolone, +/- induction therapy, urine albumin/creatinine ratio (yearly post-transplantation), plasma levels of creatinine (yearly post-transplantation) rejections (biopsy-verified), recurrence of IgAN (biopsy-verified) and course of lost graft-function.

An agreement on shared data responsibility has been drawn up between the Department of Nephrology at Odense University Hospital (data controller 1) and Aarhus University Hospital (data controller 2), respectively.

Essentiels parts of the agreement:

- Both involved parts agree on the aims and methods.

- Data controller 1 is responsible for collecting and registering data on patient participants, included from Odense University Hospital. Data controller 2 is responsible for collecting and registering data on patient participants, included from Aarhus University Hospital.

- Disclosure of information about individuals' health conditions and other confidential information from the patient records for the project is based on §46, stk 2 of the Danish Health Care Act.

- Processing of data takes place only for statistical and scientific purposes.

- Data controller 1 is responsible for the data subjects' rights which are from Odense University Hospital, while data controller 2 is for the data subjects from Aarhus University Hospital.

- In the event of a breach of personal data security by a project participant from Odense University Hospital, it is the data controller 1's responsibility to notify the data subject if he or she is alive. In the event of a breach of personal data security by a project participant from Aarhus University Hospital, it is the data controller 2's responsibility to notify the data subject if he or she is alive.

- The agreement has been signed by relevant persons on behalf of data controller 1 and data controller 2.

Collaborating researchers and departments

Department of Nephrology, Odense University Hospital

• Claus Bistrup
• Michael Dyrehauge Schultz

Department of Nephrology, Aarhus University Hospital

• Henrik Birn