Apararenone in Patients With Diabetic Nephropathy: Results of a Randomized, Double-blind, Placebo-controlled Phase 2 Dose-response Study and Open-label Extension Study


We investigated the efficacy and safety of apararenone (MT-3995), a non-steroidal compound with mineralocorticoid receptor agonist activity, in patients with stage 2 diabetic nephropathy (DN). In the dose–response period, 73 patients received placebo and 73, 74, and 73 received apararenone 2.5 mg, 5 mg, and 10 mg, respectively. As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo). UACR remission rates at week 24 were 0.0%, 7.8%, 29.0%, and 28.1% in the placebo and apararenone 2.5 mg, 5 mg, and 10 mg groups, respectively. eGFR tended to decrease and serum potassium tended to increase, but these events were not clinically significant. AE incidence increased with dose while ADR incidence did not.

Authors: Takashi Wada, Masaya Inagaki, Toru Yoshinari, Ryuji Terata, Naoko Totsuka, Miki Gotou, Gaia Hashimoto
Keywords: Apararenone, diabetic nephropathy, non-steroidal mineralocorticoid receptor agonist
DOI Number: 10.1007/s10157-020-01963-z      Publication Year: 2021

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