SGL-TX-GFR SGLT2i safety and efficacy on kidney allograft function in non-diabetic kidney transplant recipients: A randomized, double-blind, placebo controlled, national, multicenter trial.

简要总结

主要结局

次要结局

• Creatinine (umol/L)
• Total-Cholesterol
• Low-and high-density lipoproteins (LDL and HDL)
• Triglycerides
• Bilirubin
• Albumin/creatinine ratio (U-ACR) (mg/g)
• Clinical routine Tacrolimus concentration (ug/L)
• ALAT (U/L)
• Pro-BNP, renin, angiotensin-2, aldosterone
• Incidence of: Adverse events, Serious adverse events, Serious adverse reactions, Death – all cause mortality, Major Adverse Cardiac Events (MACE)
• Frequence of positive urine cultures
• Incidence of kidney transplant rejection (biopsy verified)
• Change in Systolic blood pressure (SysBP) (mmHg) and diastolic blood pressure (DiaBP) (mmHg)
• Relative incidence of out-of-target measures of clinical routine blood Tacrolimus levels
• Urine biomarkers indicative of podocyt and tubular function from selected sites
• Incidence of Post Transplant Diabetes Mellitus and prediabetes status
• Change in volume status in week 1 of therapy (Weight)
• Renal composite outcome (Incidence of graft failure (defined as return to dialysis or retransplantation), Incidence of ESRD (defined as eGFR<15 ml/min/1.73m2), Incidence of > 25% increase in creatinine