Abstract Background and Hypothesis Lupus nephritis (LN) patients under immunosuppression were excluded from the main trials with SGLT2 inhibitors. This trial aims to analyze the effect and safety of dapagliflozin in inactive LN patients with residual proteinuria. Methods We recruited adult LN patients class III, IV(±V) without activity, with proteinuria 500 mg/24 h and eGFR ≥ 20 ml/min, in the maintenance treatment with stable RASi and MMF ≤ 2 g/day. They were randomized to receive dapagliflozin on top of standard of care (SoC) therapy or not. After six months the groups were crossed over. Primary endpoint is reduction of proteinuria compared to baseline (6 and 12 months). Results From 97 screened patients, we excluded 67 due to active LN, low proteinuria or low eGFR. Thirty patients were randomized 14 to start the treatment with dapagliflozin on top of SoC and 16 to remain with the usual therapy for six months. Nine patients were excluded from the analysis due to new LN flare or lost to follow-up. The mean age was 40.6 years old (±12.3), 19 (90.5%) were female, no diabetes, and mean BMI was 26.1 (±5.2). Final analysis shows a significant reduction in the proteinuria of –36.1% in patients after 6 months of dapagliflozin as opposed to a –3.5% for those in the SoC therapy (P = 0.03). There were more reported hypotension symptoms in the dapagliflozin group, 7 cases (33.3%), but no drug withdrawal and no significant changes in blood pressure or weight in the follow-up between the groups. There was one case of urinary infection in each group, but in the same patient. Conclusions We demonstrate a significant reduction in residual proteinuria in patients with inactive LN with dapagliflozin without safety concerns.
Filho et al. (Sat,) studied this question.