DAPAGLIFLOZIN for Kidney transplant recipient

Inclusion criteria

• {"criterion_text":"- •\tObtained written informed consent"}
• {"criterion_text":"- •\tMale or female patients, age ≥ 18 years."}
• {"criterion_text":"- •\tNon-diabetic Kidney Transplant Recipient"}
• {"criterion_text":"- •\teGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization"}
• {"criterion_text":"- •\tImmunosuppressive must include Tacrolimus"}

Exclusion criteria

• {"criterion_text":"- •\tPatients who is treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization"}
• {"criterion_text":"- •\teGFR< 25 ml/min/1.73m2 (before randomization)"}
• {"criterion_text":"- •\tAlanine aminotransferase (ALAT) > 3 x upper normal limit"}
• {"criterion_text":"- •\tBilirubin > 2 x upper normal limit"}
• {"criterion_text":"- •\tPregnancy"}
• {"criterion_text":"- •\tPositive plasma hCG"}
• {"criterion_text":"- •\tBreastfeeding"}
• {"criterion_text":"- •\tKnown allergy towards SGLT2i or the content substance"}
• {"criterion_text":"- •\tPatients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn’s disease and ulcerative colitis) and structural conditions such as short bowel syndrome."}

Primary endpoints

• {"endpoint_text":"- •\tPost Transpalnt Diabetes Mellitus incidence after 6 and 12 months follow-up","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Prediabetes incidence after 6 and 12 month follow-up","definition_or_measurement_approach":""}
• {"endpoint_text":"- eGFR change after 6 and 12 month follow up.","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) measured at baseline, 6 months and 12 months."}
• {"endpoint_text":"- Proteinuria determined by Albumin/creatinine ratio (U-ACR) (mg/g)","definition_or_measurement_approach":"Measured as urinary albumin-to-creatinine ratio (U-ACR) in mg/g."}
• {"endpoint_text":"- Change in creatinine and Cholesterol after 6 and 12 month follow-up","definition_or_measurement_approach":"Serum creatinine and cholesterol measured at baseline, 6 months and 12 months."}
• {"endpoint_text":"- Incidence og urinaty tract infection determined by (positive urine culture)","definition_or_measurement_approach":"Incidence defined by positive urine culture."}
• {"endpoint_text":"- Incidence of kidney transplant rejection (biopsy verified)","definition_or_measurement_approach":"Biopsy-verified transplant rejection events."}
• {"endpoint_text":"- Renal composite outcome o\tIncidence of graft failure (defined as return to dialysis or retransplantation) o\tIncidence of ESRD (defined as eGFR<15 ml/min/1.73m2) o\tIncidence of > 25% increase in creatinine","definition_or_measurement_approach":"Composite defined by listed components: graft failure (return to dialysis or retransplantation); ESRD defined as eGFR <15 ml/min/1.73m2; >25% increase in creatinine."}
• {"endpoint_text":"- Change in Systolic blood pressure (SysBP) (mmHg) and diastolic blood pressure (DiaBP) (mmHg)","definition_or_measurement_approach":"Change in measured systolic and diastolic blood pressure in mmHg."}
• {"endpoint_text":"- Relative incidence of out-of-target measures of clinical routine blood Tacrolimus levels","definition_or_measurement_approach":"Incidence of tacrolimus blood levels outside target range as per routine clinical measurements."}
• {"endpoint_text":"- Urine biomarkers indicative of podocyt and tubular function from selected sites","definition_or_measurement_approach":"Measurement of specified urinary biomarkers of podocyte and tubular function (details not provided)."}
• {"endpoint_text":"- Incidence of Adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of Serious adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of serious adverse reactions","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of death (all cause mortality)","definition_or_measurement_approach":"All-cause mortality events recorded."}
• {"endpoint_text":"- Incidence of Major Adverse Cardiac Events (MACE)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in score for Short Form Health Survey 36 between baseline and after 12 month follow-up","definition_or_measurement_approach":"Change in SF-36 score from baseline to 12 months."}

Denmark

Earliest CTIS Part Ii Submission Date

09-03-2026

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

0

Number Of Sites

3

Number Of Participants

184

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}