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
- Registration Number
- 2024-518773-33-00
- Lead Sponsor
- Odense University Hospital
- Brief Summary
In this non-inferior randomized controlled clinical trial we determine the safety and efficacy of oral SGLT2i compared with placebo as add-on to standard-of-care on affecting kidney transplant function (eGFR) in non-diabetic kidney transplant recipients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised
- Sex
- Not specified
- Target Recruitment
- 88
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chronic eGFR slope (ml/min/1.73m2) measured from week 4, and then every 3 month until 18 month post randomization.
- Secondary Outcome Measures
Name Time Method Low-and high-density lipoproteins (LDL and HDL) Triglycerides 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 Creatinine (umol/L) Total-Cholesterol Bilirubin