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

2023-509235-39-00 Protocol SCARP Therapeutic use (Phase IV) Ongoing, recruiting

Start 30 Oct 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol SCARP

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 292
Countries 1
Sites 1

Nicotine dependence

Assessment and comparison of the efficacy of treatment in study arm and control group in 6 months.

Key facts

Sponsor
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Disorders of Environmental Origin [C21]
Trial duration
30 Oct 2025 → ongoing
Decision date (initial)
2024-03-20
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Agencja Badań Medycznych (project ABM no. 2022/ABM/03/00030)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Assessment and comparison of the efficacy of treatment in study arm and control group in 6 months.

Secondary objectives 3

  1. Assessment and comparison of the efficacy of treatment in study arm and control group in 3 months.
  2. 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.
  3. 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

Conditions and MedDRA coding

Nicotine dependence

VersionLevelCodeTermSystem organ class
20.0 PT 10057852 Nicotine dependence 100000004873
21.1 PT 10064848 Chronic kidney disease 100000004857

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Patients with nicotine dependence and chronic kidney disease
Patients will be randomized (1:1) between two arms (n=292 patients)
 Randomised Controlled None Experimental arm treatment: cytisine in tablets 1.5 mg; duration of therapy: 12 weeks
Control arm treatment: nicotine replacement therapy - transdermal patch 10mg/16h / 15mg/16h / 25mg/16h and lozenges 2mg / 4mg; duration of therapy: 12 weeks

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Patient (woman or man) who wants to participate in the study and is able to give a written informed consent.
  2. Age over or equal to 18 and under 65.
  3. Current daily cigarette smoker - a person who smokes tobacco products every day or almost every day for at least 3 months.
  4. Motivation and willingness to try to quit smoking with medication, assessed in conversation with the patient.
  5. 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.
  6. 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
  7. Telephone access.

Exclusion criteria 11

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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 endpoints 3

  1. Abstinence after 3 months from Designated Day Zero (subject to the grace period) defined as abstinence at the end of treatment.
  2. 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.
  3. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Desmoxan, 1,5 mg, tabletki

PRD7141186 · Product

Active substance
Cytisinicline
Substance synonyms
(1R,5S)-1,2,3,4,5,6-HEXAHYDRO-1,5-METHANO-8H-PYRIDO(1,2-A)(1,5)DIAZOCIN-8-ONE, (1R,5S)-1,2,3,4,5,6-hexahydro-8H-1,5-methanopyrido[1,2-a][1,5]diazocin-8-one, CYTISINE
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
9 mg milligram(s)
Max total dose
573 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
N07BA04 — -
Marketing authorisation
24354
MA holder
AFLOFARM FARMACJA POLSKA SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Prolonged duration of the treatment. 12 weeks of therapy instead of 25 days.

Comparator 5

Nicorette Invisipatch, 25 mg/ 16 h system transdermalny, plaster

PRD2255964 · Product

Active substance
Nicotine
Pharmaceutical form
TRANSDERMAL PATCH
Route of administration
TRANSDERMAL USE
Max daily dose
25 mg milligram(s)
Max total dose
2100 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
N07BA01 — NICOTINE
Marketing authorisation
14883
MA holder
MCNEIL AB
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Nicorette Coolmint, 2 mg, tabletki do ssania

PRD2127714 · Product

Active substance
Nicotine
Pharmaceutical form
COMPRESSED LOZENGE
Route of administration
ORAL
Max daily dose
24 mg milligram(s)
Max total dose
2016 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
N07BA01 — NICOTINE
Marketing authorisation
19863
MA holder
MCNEIL AB
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Nicorette Invisipatch, 10 mg/ 16 h system transdermalny, plaster

PRD2255931 · Product

Active substance
Nicotine
Pharmaceutical form
TRANSDERMAL PATCH
Route of administration
TRANSDERMAL USE
Max daily dose
10 mg milligram(s)
Max total dose
840 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
N07BA01 — NICOTINE
Marketing authorisation
14881
MA holder
MCNEIL AB
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Nicorette Invisipatch, 15 mg/ 16 h system transdermalny, plaster

PRD2256053 · Product

Active substance
Nicotine
Pharmaceutical form
TRANSDERMAL PATCH
Route of administration
TRANSDERMAL USE
Max daily dose
15 mg milligram(s)
Max total dose
1260 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
N07BA01 — NICOTINE
Marketing authorisation
14882
MA holder
MCNEIL AB
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Nicorette Fruit, 2 mg, tabletki do ssania

PRD5756945 · Product

Active substance
Nicotine
Pharmaceutical form
COMPRESSED LOZENGE
Route of administration
ORAL
Max daily dose
24 mg milligram(s)
Max total dose
2016 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
N07BA01 — NICOTINE
Marketing authorisation
24430
MA holder
MCNEIL AB
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

12 Total trials 5 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Address
Ul. Wilhelma Konrada Roentgena 5
City
Warsaw
Postcode
02-781
Country
Poland

Scientific contact point

Organisation
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Contact name
Magdalena Cedzyńska

Public contact point

Organisation
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Contact name
Magdalena Cedzyńska

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Poland Ongoing, recruiting 292 1
Rest of world — 0 —

Investigational sites

Poland

1 site · Ongoing, recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Klinika Medycyny Transplantacyjnej, Nefrologii i Chorób Wewnętrznych, Ul. Ulica Nowogrodzka 59, 02-006, Warsaw

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Poland 2025-10-30 2025-10-30

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-11-15 Poland Acceptable with conditions
2024-03-18
 2024-03-20
2 SUBSTANTIAL MODIFICATION SM-1 2024-06-07 Poland Acceptable
2024-07-22
 2024-07-29

Related clinical trials