2023-509235-39-00RecruitingPhase 4
Cytisine in prolonged dosage versus Nicotine Replacement Therapy in nicotine-dependent patients with Chronic Kidney Disease - single-center, randomized, non-inferiority clinical trial.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Assessment and comparison of the efficacy of treatment in study arm and control group in 6 months.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 292 (estimated)
- First submitted
- 15 Nov 2023
- Start date
- 30 Oct 2025
- Lead sponsor
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Diseases
- Chronic kidney disease
- EU CT number
- 2023-509235-39-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 292
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who smoke every day and want to quit, and who have chronic kidney disease of at least stage 3.
- Age
- From 18 to under 65 years.
- Sex
- Women and men can join.
- Disease stage
- Chronic kidney disease of at least stage 3 (eGFR MDRD below 60 ml/min and above 15 ml/min for at least 3 months).
- Earlier treatment
- Must not have taken other smoking cessation medicines (bupropion, varenicline, nortriptyline) in the last 4 weeks. Must not have been in another drug trial in the last 4 weeks.
Main reasons for not taking part
- Allergy to cytisine, its other ingredients or nicotine products
- Liver damage signs (AST/ALT more than 2x above normal)
- Uncontrolled high blood pressure above 160/100 mm Hg
- Heart attack, stroke or heart failure needing hospital care in the last 3 months
- Pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Recent history of myocardial infarction, stroke, heart failure requiring hospitalization (within 3 months before randomization).
Other illness
- Hypersensitivity to cytisine or any of the excipients or nicotine preparations.
- Currently uncontrolled hypertension above 160/100 mm Hg.
- Documented diagnosis of: schizophrenia, bipolar psychoaffective disorder, epilepsy, symptoms of moderate to severe depression
Lab values
- Biochemical features of liver damage (AST/ALT > 2x above normal).
Other
- Pheochromocytoma of the adrenal glands.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.