scholarly journals Efficacy and safety of Privigen ® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)

2013 ◽  
Vol 18 (2) ◽  
pp. 130-140 ◽  
Author(s):  
Jean‐Marc Léger ◽  
Jan L. De Bleecker ◽  
Claudia Sommer ◽  
Wim Robberecht ◽  
Mika Saarela ◽  
...  
Keyword(s):  
Chronic Inflammatory Demyelinating Polyneuropathy ◽  
Demyelinating Polyneuropathy ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Open Label ◽  
Inflammatory Demyelinating Polyneuropathy ◽  
Open Label Phase ◽  
Phase Iii Study

scholarly journals Efficacy and safety of esaxerenone (CS-3150) in Japanese patients with type 2 diabetes and macroalbuminuria: a multicenter, single-arm, open-label phase III study

2021 ◽  
Author(s):  
Sadayoshi Ito ◽  
Naoki Kashihara ◽  
Kenichi Shikata ◽  
Masaomi Nangaku ◽  
Takashi Wada ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Renin Angiotensin System ◽  
Japanese Patients ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Open Label Phase ◽  
Phase Iii Study

Abstract Background Esaxerenone has potential renoprotective effects and reduces the urinary albumin-to-creatinine ratio (UACR) in patients with diabetic kidney disease and overt nephropathy. We investigated the efficacy and safety of esaxerenone in Japanese patients with type 2 diabetes (T2D) and macroalbuminuria (UACR ≥ 300 mg/g creatinine). Methods We conducted a multicenter, single-arm, open-label phase III study in 56 patients with T2D and UACR ≥ 300 mg/g creatinine with estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 and treated with a renin–angiotensin system inhibitor. Patients received esaxerenone for 28 weeks at 1.25 mg/day initially with titration to 2.5 mg/day based on serum potassium (K+) monitoring. Efficacy was evaluated as the change in UACR from baseline to week 28. Safety endpoints included adverse events (AEs), incidence of serum K+ increase, and change in eGFR from baseline. Results UACR decreased by 54.6% (95% CI 46.9%, 61.3%) on average from baseline (544.1 mg/g creatinine) to the end of treatment (246.8 mg/g creatinine); 51.8% of patients showed improvement to early nephropathy. AE incidence was 69.6%. Three patients (5.4%) had serum K+ levels ≥ 6.0 mEq/L or ≥ 5.5 mEq/L on two consecutive occasions. Hyperkalemia in two patients was transient and resolved during the treatment period. One patient discontinued following two consecutive serum K+ values ≥ 5.5 mEq/L. The maximum change from baseline in eGFR was − 8.3 mL/min/1.73 m2 at week 24. Conclusions Esaxerenone reduced UACR in Japanese patients with T2D and UACR ≥ 300 mg/g creatinine; more than half experienced a transition from UACR ≥ 300 mg/g creatinine to UACR < 300 mg/g creatinine. Clinical trial registration JapicCTI-173696

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