Table 2.
Randomised clinical trials so far and ongoing.
| Study | Population | Intervention | Results with SGLT2i |
|---|---|---|---|
| Halden et al., 2019. (12) |
n = 44 (22 patients on empagliflozin) PTDM with KTR >1 year, eGFR >30 ml/min/1.73 m2 |
Empagliflozin versus placebo | • Reduction of HbA1c: −0.2% • Reduction of body weight • No changes in BP or eGFR • No interactions observed with immunosuppressive drugs • One case of urosepsis and one mycotic infection |
| CREST-KT ongoing (25) | 72 KTR with (n=36) and without (n=36) T2DM | Empagliflozin versus placebo | Primary outcomes: •Change in kidney function as measured by albuminuria •Change in cardiac structure •Change in blood insulin level •Change in fasting blood sugar •Number of UTI and genital infections |
| INFINITI 2019 ongoing (26) | 52 KTR with T2DM or PTDM | Dapagliflozin versus Placebo |
Primary outcome: determine if dapagliflozin is superior to placebo in reduction of BP in KTR. |
| Can Dapagliflozin Preserve Structure and Function in KT? Ongoing (27) |
330 KTR | Dapagliflozin versus Placebo |
Primary outcome: •Effect of Dapagliflozin on the GFR slope in KTR. • Difference in eGFR slope between groups |
| The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & GLP-1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients (HALLMARK) Ongoing (28) |
20 KTR, with and without T2DM | Dapagliflozin Semaglutide | Primary outcome: • Mechanisms and safety of 12 weeks of dapagliflozin and semaglutide combination therapy. |
| Effect of adding dapagliflozin to allograft dysfunction of renal transplanted patients Ongoing (29) |
220 KTR, with and without T2DM | Dapagliflozin versus Placebo |
Primary outcome: •Estimate the mean delta difference of the eGFR, between baseline and one year after randomization. |
| The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Severe CKD (30) | 1500 patients -with advanced CKD, i.e. an eGFR ≤25mL/min*1.73m2 -on dialysis with a residual diuresis >500 mL/24h (at least 3 months after start of dialysis) -KTR and an eGFR ≤45mL/min/1.73m2 (at least 6 months after transplantation) |
Dapagliflozin 10 mg/day or matching placebo | Combined endpoint of all-cause mortality, kidney failure, and hospitalization for heart failure in the overall study population |