Cytisine in prolonged dosage versus Nicotine Replacement Therapy in nicotine-dependent patients with Chronic Kidney Disease - single-center, randomized, non-inferiority clinical trial.
- Conditions
- icotine dependence, Chronic Kidney DiseaseMedDRA version: 20.0Level: PTClassification code: 10057852Term: Nicotine dependence Class: 100000004873Therapeutic area: Diseases [C] - Disorders of Environmental Origin [C21]MedDRA version: 21.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857
- Registration Number
- CTIS2023-509235-39-00
- Lead Sponsor
- arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 292
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment and comparison of the efficacy of treatment in study arm and control group in 6 months.;Secondary Objective: Assessment and comparison of the efficacy of treatment in study arm and control group in 3 months., Assessment and comparison of the severity of withdrawal symptoms in study arm and control group in 7±2, 14±2 and 30±5, 42±5 days., Assessment and comparison of the occurrence and severity of adverse events in study arm and control group in 7±2, 14±2, 30±5, 42±5, 60±5, 84-90 and 180±5 days;Primary end point(s): 6 months of abstinence from tobacco products defined as smoking no more than 5 cigarettes in the period from Designated Day Zero (subject to the grace period).
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Abstinence after 3 months from Designated Day Zero (subject to the grace period) defined as abstinence at the end of treatment.;Secondary end point(s):Assessment and comparison of the severity of withdrawal symptoms in the study arm and control group in 7±2, 14±2 and 30±5 days after the start of treatment.;Secondary end point(s):Assessment and comparison of the occurrence and severity of adverse events in the study arm and control group after 7±2, 14±2, 30±5 and 84-90 days after the start of treatment.