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.

Conditions

Kidney transplant recipients

Brief summary

Chronic eGFR slope (ml/min/1.73m2) measured from week 4, and then every 3 month until 18 month post randomization.

Detailed description

Albumin/creatinine ratio (U-ACR) (mg/g), Creatinine (umol/L), Total-Cholesterol, Low-and high-density lipoproteins (LDL and HDL), Triglycerides, Clinical routine Tacrolimus concentration (ug/L), ALAT (U/L), Bilirubin, Pro-BNP, renin, angiotensin-2, aldosterone, Frequence of positive urine cultures, Incidence of Post Transplant Diabetes Mellitus and prediabetes status, Change in volume status in week 1 of therapy (Weight), Incidence of kidney transplant rejection (biopsy verified), 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, 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: Adverse events, Serious adverse events, Serious adverse reactions, Death – all cause mortality, Major Adverse Cardiac Events (MACE)

Related papers

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Interventions

DRUGForxiga 10 mg film-coated tablets

DRUGPlacebo Capsules is manufactured by Region Hovedstadens Pharmacy. One placebo tablet (8 mm

DRUGwhite

DRUGconvex

DRUGlactosemonohydrate) is placed into an empty

DRUGopaque gelatin capsule

DRUGsize AA. The capsule is filled with Lactose Monohydrate before being sealed using a manual capsule-filling device. For further information see appendix sIMPD for placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Chronic eGFR slope (ml/min/1.73m2) measured from week 4, and then every 3 month until 18 month post randomization.	—

Secondary

Measure	Time frame
Albumin/creatinine ratio (U-ACR) (mg/g), Creatinine (umol/L), Total-Cholesterol, Low-and high-density lipoproteins (LDL and HDL), Triglycerides, Clinical routine Tacrolimus concentration (ug/L), ALAT (U/L), Bilirubin, Pro-BNP, renin, angiotensin-2, aldosterone, Frequence of positive urine cultures, Incidence of Post Transplant Diabetes Mellitus and prediabetes status, Change in volume status in week 1 of therapy (Weight), Incidence of kidney transplant rejection (biopsy verified), 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, 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: Adverse events, Serious adverse	—

Measure

Time frame

Albumin/creatinine ratio (U-ACR) (mg/g), Creatinine (umol/L), Total-Cholesterol, Low-and high-density lipoproteins (LDL and HDL), Triglycerides, Clinical routine Tacrolimus concentration (ug/L), ALAT (U/L), Bilirubin, Pro-BNP, renin, angiotensin-2, aldosterone, Frequence of positive urine cultures, Incidence of Post Transplant Diabetes Mellitus and prediabetes status, Change in volume status in week 1 of therapy (Weight), Incidence of kidney transplant rejection (biopsy verified), 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, 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: Adverse events, Serious adverse

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Countries

Denmark

Outcome results

None listed