Clinical trial • Phase IV • Nephrology|Psychiatry
cytisinicline (cytisine) for Nicotine dependence | Chronic kidney disease
Phase IV trial of cytisinicline (cytisine) for Nicotine dependence | Chronic kidney disease.
Overview
- Trial Therapeutic Area
- Nephrology|Psychiatry
- Trial Disease
- Nicotine dependence | Chronic kidney disease
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-11-2023
- First CTIS Authorization Date
- 20-03-2024
Trial design
Randomised, open-label, control arm: nicotine replacement therapy - transdermal patch 10 mg/16 h, 15 mg/16 h, or 25 mg/16 h and lozenges 2 mg / 4 mg; duration of therapy: 12 weeks. Phase IV trial across 1 site in Poland.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control arm: nicotine replacement therapy - transdermal patch 10 mg/16 h, 15 mg/16 h, or 25 mg/16 h and lozenges 2 mg / 4 mg; duration of therapy: 12 weeks.
- Target Sample Size
- 292
- Trial Duration For Participant
- 180
Eligibility
Recruits 292 Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrols adults only (Age over or equal to 18 and under 65). Participants must be able to give written informed consent ("Patient (woman or man) who wants to participate in the study and is able to give a written informed consent."). No assent procedures described..
- Pregnancy Exclusion
- Pregnancy or breastfeeding.
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrols adults only (Age over or equal to 18 and under 65). Participants must be able to give written informed consent ("Patient (woman or man) who wants to participate in the study and is able to give a written informed consent."). No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Patient (woman or man) who wants to participate in the study and is able to give a written informed consent."}
- {"criterion_text":"- Age over or equal to 18 and under 65."}
- {"criterion_text":"- Current daily cigarette smoker - a person who smokes tobacco products every day or almost every day for at least 3 months."}
- {"criterion_text":"- Motivation and willingness to try to quit smoking with medication, assessed in conversation with the patient."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Telephone access."}
Exclusion criteria
- {"criterion_text":"- Hypersensitivity to cytisine or any of the excipients or nicotine preparations."}
- {"criterion_text":"- Biochemical features of liver damage (AST/ALT > 2x above normal)."}
- {"criterion_text":"- Currently uncontrolled hypertension above 160/100 mm Hg."}
- {"criterion_text":"- Recent history of myocardial infarction, stroke, heart failure requiring hospitalization (within 3 months before randomization)."}
- {"criterion_text":"- Pheochromocytoma of the adrenal glands."}
- {"criterion_text":"- Documented diagnosis of: schizophrenia, bipolar psychoaffective disorder, epilepsy, symptoms of moderate to severe depression"}
- {"criterion_text":"- Current other addiction (alcohol, other psychoactive substances)."}
- {"criterion_text":"- Pregnancy or breastfeeding."}
- {"criterion_text":"- Male or female persons of childbearing potential who do not consent to the use of adequate birth control methods during the study treatment period."}
- {"criterion_text":"- Treatment in the last 4 weeks with other smoking cessation medications (bupropion, varenicline, nortriptyline)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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).","definition_or_measurement_approach":"Abstinence defined as smoking no more than 5 cigarettes in the period from Designated Day Zero (subject to the grace period). Measured at 6 months."}
Secondary endpoints
- {"endpoint_text":"- Abstinence after 3 months from Designated Day Zero (subject to the grace period) defined as abstinence at the end of treatment.","definition_or_measurement_approach":"Abstinence at 3 months defined as abstinence at the end of treatment."}
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Severity of withdrawal symptoms assessed and compared at 7±2, 14±2 and 30±5 days after treatment start."}
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Occurrence and severity of adverse events assessed and compared at 7±2, 14±2, 30±5 and 84-90 days after treatment start."}
Recruitment
- Planned Sample Size
- 292
- Recruitment Window Months
- 43
- Consent Approach
- Written informed consent required from participant: "Patient (woman or man) who wants to participate in the study and is able to give a written informed consent." Adults only (Age over or equal to 18 and under 65). No assent procedures or additional consent language information provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 292
Poland
- Earliest CTIS Part Ii Submission Date
- 06-02-2024
- Latest Decision Or Authorization Date
- 29-07-2024
- Processing Time Days
- 174
- Number Of Sites
- 1
- Number Of Participants
- 292
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Klinika Medycyny Transplantacyjnej, Nefrologii i Chorób Wewnętrznych
- Contact Person Name
- Jakub Kucharz
- Contact Person Email
- jakub.kucharz@nio.gov.pl
Sponsor
Primary sponsor
- Full Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- Desmoxan, 1,5 mg, tabletki
- Active Substance
- cytisinicline (cytisine)
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 1.5 mg (tablet)
- Dose Levels
- Product labelled 1.5 mg tablets; max daily dose amount 9 mg
- Maximum Dose
- 9 mg (max daily dose amount)
- Investigational Product Name
- Nicorette Invisipatch, 10 mg/16 h system transdermalny, plaster
- Active Substance
- nicotine
- Modality
- Small molecule
- Routes Of Administration
- TRANSDERMAL USE
- Route
- TRANSDERMAL
- Authorisation Status
- Authorised
- Starting Dose
- 10 mg/16 h (patch)
- Dose Levels
- 10 mg/16 h; 15 mg/16 h; 25 mg/16 h patches
- Frequency
- 16 hours per patch application (as product name indicates)
- Maximum Dose
- 10 mg (max daily dose amount field shows 10 mg for this product)
- Investigational Product Name
- Nicorette Invisipatch, 15 mg/16 h system transdermalny, plaster
- Active Substance
- nicotine
- Modality
- Small molecule
- Routes Of Administration
- TRANSDERMAL USE
- Route
- TRANSDERMAL
- Authorisation Status
- Authorised
- Starting Dose
- 15 mg/16 h (patch)
- Dose Levels
- 10 mg/16 h; 15 mg/16 h; 25 mg/16 h patches
- Frequency
- 16 hours per patch application (as product name indicates)
- Maximum Dose
- 15 mg (max daily dose amount field shows 15 mg for this product)
- Investigational Product Name
- Nicorette Invisipatch, 25 mg/16 h system transdermalny, plaster
- Active Substance
- nicotine
- Modality
- Small molecule
- Routes Of Administration
- TRANSDERMAL USE
- Route
- TRANSDERMAL
- Authorisation Status
- Authorised
- Starting Dose
- 25 mg/16 h (patch)
- Dose Levels
- 10 mg/16 h; 15 mg/16 h; 25 mg/16 h patches
- Frequency
- 16 hours per patch application (as product name indicates)
- Maximum Dose
- 25 mg (max daily dose amount field shows 25 mg for this product)
- Investigational Product Name
- Nicorette Coolmint, 2 mg, tabletki do ssania
- Active Substance
- nicotine
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 2 mg lozenge
- Dose Levels
- Lozenges 2 mg (and product list includes 4 mg lozenges in comparator description)
- Maximum Dose
- 24 mg (max daily dose amount field shows 24 mg for some lozenge products)
- Investigational Product Name
- Nicorette Fruit, 2 mg, tabletki do ssania
- Active Substance
- nicotine
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 2 mg lozenge
- Dose Levels
- Lozenges 2 mg (and product list includes 4 mg lozenges in comparator description)
- Maximum Dose
- 24 mg (max daily dose amount field shows 24 mg for this product set)
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