DAPAGLIFLOZIN for Kidney transplant recipient

Inclusion criteria

• {"criterion_text":"- Obtained written informed consent\n- Male or female patients, age ≥ 18 years\n- Non-diabetic Kidney Transplant Recipient\n- > 6 months post-transplant\n- eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization\n- Immunosuppressive must include Tacrolimus\n- Negative plasma hCG in fertile women, and acceptance of the use of contraception during the course of the study."}

Exclusion criteria

• {"criterion_text":"- Patients treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization\n- eGFR< 25 ml/min/1.73m2 (before randomization)\n- Alanine aminotransferase (ALAT) > 3 x upper normal limit\n- Bilirubin > 2 x upper normal limit\n- Pregnancy\n- Breastfeeding\n- Known allergy towards SGLT2i or the content substance\n- Known intestinal bowel disease"}

Primary endpoints

• {"endpoint_text":"- Chronic eGFR slope (ml/min/1.73m2) measured from week 4, and then every 3 month until 18 month post randomization.","definition_or_measurement_approach":"eGFR slope measured starting from week 4, then every 3 months up to 18 months post-randomization."}

Secondary endpoints

• {"endpoint_text":"- Albumin/creatinine ratio (U-ACR) (mg/g)\n- Creatinine (umol/L)\n- Total-Cholesterol\n- Low-and high-density lipoproteins (LDL and HDL)\n- Triglycerides\n- Clinical routine Tacrolimus concentration (ug/L)\n- ALAT (U/L)\n- Bilirubin\n- Pro-BNP, renin, angiotensin-2, aldosterone\n- Frequence of positive urine cultures\n- Incidence of Post Transplant Diabetes Mellitus and prediabetes status\n- Change in volume status in week 1 of therapy (Weight)\n- Incidence of kidney transplant rejection (biopsy verified)\n- 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\n- Change in Systolic blood pressure (SysBP) (mmHg) and diastolic blood pressure (DiaBP) (mmHg)\n- Relative incidence of out-of-target measures of clinical routine blood Tacrolimus levels\n- Urine biomarkers indicative of podocyt and tubular function from selected sites\n- Incidence of: Adverse events, Serious adverse events, Serious adverse reactions, Death – all cause mortality, Major Adverse Cardiac Events (MACE)","definition_or_measurement_approach":"Endpoints as listed in protocol; where measurement approach specified it is via routine clinical/laboratory measurements (e.g., U-ACR, creatinine, lipid panels, Tacrolimus concentration, ALAT, bilirubin, biomarkers, urine cultures), and clinical adjudication for events (e.g., biopsy-verified rejection, graft failure, MACE). Specific measurement schedules are not further detailed in the available JSON beyond routine assessments."}

Methods

• Recruitment arrangements document listed (K1_Recruitment arrangements) - details not extractable from provided JSON.
• Recruitment letter for e-boks (document listed) - indicates use of Denmark's e-Boks digital mail system for recruitment communication.

Denmark

Earliest CTIS Part Ii Submission Date

02-06-2025

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

18

Number Of Sites

4

Number Of Participants

88

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":"1","organisation_type":"Hospital/Clinic/Other health care facility"}