Propagermanium administration for patients with type 2 diabetes and nephropathy: A randomized pilot trial
Autor: | Yasunori Iwata, Erika Hamaguchi, Akinori Hara, Koshino Y, Kazuya Takasawa, Ikeda K, Yukimasa Hisada, Miho Shimizu, Hirokazu Kakuda, Tadashi Toyama, Kiyoki Kitagawa, Motoo Kobayashi, Toshiya Okumura, Takashi Wada, Norihiko Sakai |
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Rok vydání: | 2020 |
Předmět: |
medicine.medical_specialty
kidney Endocrinology Diabetes and Metabolism Type 2 diabetes Propagermanium lcsh:Diseases of the endocrine glands. Clinical endocrinology albuminuria Nephropathy chemistry.chemical_compound Internal medicine Diabetes mellitus Original Research Articles Medicine Original Research Article Adverse effect lcsh:RC648-665 Proteinuria diabetes business.industry propagermanium medicine.disease chemistry Concomitant Albuminuria CCR2 medicine.symptom business MCP‐1 |
Zdroj: | Endocrinology, Diabetes & Metabolism Endocrinology, Diabetes & Metabolism, Vol 3, Iss 3, Pp n/a-n/a (2020) |
ISSN: | 2398-9238 |
Popis: | Summary Aims 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. Materials and methods 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 m2. 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. Results 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%, P = .33). No severe adverse events or renal events were observed during the study. Conclusion 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. 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. Changes in albuminuria by PG in addition to the usual care were 25.0% (95% CI −20.4%, 96.5%, P = .33). No severe adverse events or renal events were observed during the study. |
Databáze: | OpenAIRE |
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