Hara Akinori, Shimizu Miho, Hamaguchi Erika, Kakuda Hirokazu, Ikeda Kenzo, Okumura Toshiya, Kitagawa Kiyoki, Koshino Yoshitaka, Kobayashi Motoo, Takasawa Kazuya, Hisada Yukimasa, Toyama Tadashi, Iwata Yasunori, Sakai Norihiko, Wada Takashi
Division of Nephrology Kanazawa University Hospital Kanazawa Japan.
Department of Environmental and Preventive Medicine Faculty of Medicine Institute of Medical, Pharmaceutical and Health Sciences Kanazawa University Kanazawa Japan.
Endocrinol Diabetes Metab. 2020 Jun 12;3(3):e00159. doi: 10.1002/edm2.159. eCollection 2020 Jul.
We assessed the potential efficacy and safety of propagermanium (PG), an organic compound that inhibits the C-C chemokine receptor type 2, administration in patients with type 2 diabetes and nephropathy. Furthermore, we assessed the feasibility of future studies.
We recruited patients from nine medical institutions in Japan for this randomized, open-label, parallel two-arm pilot trial. Inclusion criteria were diagnosis of type 2 diabetes, age 30-75 years, dipstick proteinuria of ≥1+ or urinary albumin-to-creatinine ratio (UACR) of ≥30 mg/g and estimated glomerular filtration rate of ≥30 mL/min/1.73 m. Patients were randomly assigned (1:2) using a minimization algorithm to either continuing usual care or concomitant administration of 30 mg PG per day for 12 months. The primary outcome was the change in UACR from baseline to 12 months. We also collected safety information for all patients who received at least one dose of PG.
We enrolled 29 patients, 10 were assigned to continue usual care and 19 to receive PG. Changes in UACR by PG in addition to the usual care were 25.0% (95% CI -20.4%, 96.5%, = .33). No severe adverse events or renal events were observed during the study.
Although the treatment with PG was generally well tolerated, the dosage of 30 mg/d for 12 months did not reduce albuminuria when used in addition to usual care in patients with type 2 diabetes and nephropathy. Efficacy of PG should be verified in future definitive trials.
我们评估了抑制C-C趋化因子受体2型的有机化合物丙帕锗（PG）对2型糖尿病肾病患者给药的潜在疗效和安全性。此外，我们评估了未来研究的可行性。
我们从日本的9家医疗机构招募患者进行这项随机、开放标签、平行双臂的试点试验。纳入标准为2型糖尿病诊断、年龄30 - 75岁、试纸法蛋白尿≥1+或尿白蛋白与肌酐比值（UACR）≥30 mg/g以及估计肾小球滤过率≥30 mL/min/1.73m²。患者使用最小化算法以1:2的比例随机分配至继续常规治疗或每天联合服用30 mg PG，为期12个月。主要结局是从基线到12个月时UACR的变化。我们还收集了所有接受至少一剂PG患者的安全信息。
我们纳入了29名患者，10名被分配继续常规治疗，19名接受PG治疗。PG联合常规治疗时UACR的变化为25.0%（95%CI -20.4%，96.5%，P = 0.33）。研究期间未观察到严重不良事件或肾脏事件。
尽管PG治疗总体耐受性良好，但对于2型糖尿病肾病患者，在常规治疗基础上使用30 mg/d持续12个月并未降低蛋白尿。PG的疗效应在未来的确定性试验中得到验证。
