Cytisine in prolonged dosage versus Nicotine Replacement Therapy in nicotine-dependent patients with Chronic Kidney Disease - single-center, randomized, non-inferiority clinical trial. - SCARP

arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy0 个研究点目标入组 292 人开始时间: 2023年11月15日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Patient (woman or man) who wants to participate in the study and is able to give a written informed consent., Age over or equal to 18 and under 65., Current daily cigarette smoker - a person who smokes tobacco products every day or almost every day for at least 3 months., Motivation and willingness to try to quit smoking with medication, assessed in conversation with the patient., Chronic kidney disease at least stage 3, defined as impaired glomerular filtration eGFR MDRD < 60 ml/min and > 15 ml/min persisting for at least 3 months preceding qualification for the study., Women of reproductive age: a) exclusion of pregnancy by testing the concentration of beta HCG in the urine; b) consent to use a highly effective method of contraception during treatment, Telephone access.

•Hypersensitivity to cytisine or any of the excipients or nicotine preparations., Treatment in the last 4 weeks with other smoking cessation medications (bupropion, varenicline, nortriptyline)., Participation in another clinical trial of the drug in the 4 weeks before randomization., Biochemical features of liver damage (AST/ALT > 2x above normal)., Currently uncontrolled hypertension above 160/100 mm Hg., Recent history of myocardial infarction, stroke, heart failure requiring hospitalization (within 3 months before randomization)., Pheochromocytoma of the adrenal glands., Documented diagnosis of: schizophrenia, bipolar psychoaffective disorder, epilepsy, symptoms of moderate to severe depression, Current other addiction (alcohol, other psychoactive substances)., Pregnancy or breastfeeding., Male or female persons of childbearing potential who do not consent to the use of adequate birth control methods during the study treatment period.

发起方

arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy