SGL-TX-PTDM: SGLT2i effect on PTDM development and kidney allograft function in kidney transplant recipients: A randomized, double-blind, placebo controlled, national multicenter trial

Conditions

Kidney transplant recipients

Brief summary

• Post Transpalnt Diabetes Mellitus incidence after 6 and 12 months follow-up

Detailed description

Prediabetes incidence after 6 and 12 month follow-up, eGFR change after 6 and 12 month follow up., Proteinuria determined by Albumin/creatinine ratio (U-ACR) (mg/g), Change in creatinine and Cholesterol after 6 and 12 month follow-up, Incidence og urinaty tract infection determined by (positive urine culture), Incidence of kidney transplant rejection (biopsy verified), Renal composite outcome o Incidence of graft failure (defined as return to dialysis or retransplantation) o Incidence of ESRD (defined as eGFR<15 ml/min/1.73m2) o 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, Incidence of Serious adverse events, Incidence of serious adverse reactions, Incidence of death (all cause mortality), Incidence of Major Adverse Cardiac Events (MACE), Change in score for Short Form Health Survey 36 between baseline and after 12 month follow-up

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGForxiga 10 mg film-coated tablets

DRUGThe placebo medicinal product is manufactured by the Capital Region Hospital Pharmacy (Region Hovedstadens Apotek). The placebo tablet is white

DRUGround

DRUGand biconvex

DRUGwith a diameter of 8 mm. It consists of lactose monohydrate

DRUGpotato starch

DRUGgelatin A

DRUGpurified water

DRUGmagnesium stearate (MF2V)

DRUGand talc. The tablets are over-encapsulated in an opaque hard gelatin capsule identical in appearance to the capsule containing the active Forxiga® tablet. For further details

DRUGplease refer to document G1_sIMPD_Q Placebo.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Post Transpalnt Diabetes Mellitus incidence after 6 and 12 months follow-up	—

Secondary

Measure	Time frame
Prediabetes incidence after 6 and 12 month follow-up, eGFR change after 6 and 12 month follow up., Proteinuria determined by Albumin/creatinine ratio (U-ACR) (mg/g), Change in creatinine and Cholesterol after 6 and 12 month follow-up, Incidence og urinaty tract infection determined by (positive urine culture), Incidence of kidney transplant rejection (biopsy verified), Renal composite outcome o Incidence of graft failure (defined as return to dialysis or retransplantation) o Incidence of ESRD (defined as eGFR<15 ml/min/1.73m2) o 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, Incidence of Serious adverse events, Incidence of serious adverse reactions, Incidence of death (all cause mortality), Incidence	—

Measure

Time frame

Prediabetes incidence after 6 and 12 month follow-up, eGFR change after 6 and 12 month follow up., Proteinuria determined by Albumin/creatinine ratio (U-ACR) (mg/g), Change in creatinine and Cholesterol after 6 and 12 month follow-up, Incidence og urinaty tract infection determined by (positive urine culture), Incidence of kidney transplant rejection (biopsy verified), Renal composite outcome o Incidence of graft failure (defined as return to dialysis or retransplantation) o Incidence of ESRD (defined as eGFR<15 ml/min/1.73m2) o 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, Incidence of Serious adverse events, Incidence of serious adverse reactions, Incidence of death (all cause mortality), Incidence

—

Outcome results

None listed