Short summary

The SGL-TX study consists of 3 double-blind, placebo-controlled, national, multicenter studies that will examine SGLT2i vs. placebo in non-diabetic kidney transplant recipients, determining the effect of SGLT2i on kidney allograft function, post-transplant diabetes mellitus, and kidney allograft oxygen tension.

Rationale

The SGL-TX Study Background Kidney transplant recipients suffer from immunosuppressive side effects such as post transplant diabetes mellitus (PTDM) and loss of kidney transplant function. The effect of SGLT2i is positive in chronic kidney disease patients, but the effect is not examined in non-diabetic kidney transplant recipients. Hypothesis SGLT2i vs. placebo in non-diabetic kidney transplant recipients will effect; A. Loss of kidney transplant function B. PTDM C. Kidney transplant oxygen tension Aim Investigate SGLT2i effect in non-diabetic kidney transplant recipients regarding kidney transplant function, PTDM and kidney transplant oxygenation. Methods 3 RCT studies with respectively 88, 194 and 8 non-diabetic kidney transplant recipients randomly assigned to receive SGLT2i or placebo. Primary outcome respectively decline in eGFR, PTDM and cortex oxygenation. Results Results await Conclusions If loss of kidney transplant function can be diminished by SGLT2i, equivalent to non-transplanted non-diabetic kidney patients, this will prolong the half-lives of transplanted kidneys, thus decreasing the need for repeat transplantation and dialysis. Further, if we succeed in reducing PTDM, the overall survival of kidney transplant recipients will be improved. Perspective: This will overall result in a shorter waiting list for kidney transplantation. If we are successful, the health and well-being of kidney transplant recipients will be improved to benefit the burden of kidney diseases on healthcare systems worldwide.

Description of the cohort

Non-diabetic kidney transplant recipients followed in the outpatient clinic at OUH, RH, AUH, and Gødstrup.

Data and biological material

BOLD-MRI, blood and urine samples, urine culture. Bloodpressure, weight. Data from the electronic patient journal: demografic, diagnosis, comorbidity, medicine

Collaborating researchers and departments

Department of nephrology OUH, RH, AUH and Gødstrup

OPEN, OUH

Radiology Department, OUH

Sygehus Apotek Fyn

Region Hovedstadens Apotek

Department of Clinical Biochemistry, OUH