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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509235-39-00
Acronym
SCARP
Enrollment
292
Registered
2024-03-20
Start date
2025-10-30
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine dependence, Chronic Kidney Disease

Brief summary

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).

Detailed description

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

Interventions

DRUGNicorette Invisipatch
DRUG15 mg/ 16 h system transdermalny
DRUGDesmoxan
DRUG1
DRUG5 mg
DRUGtabletki
DRUGNicorette Fruit
DRUG2 mg
DRUGtabletki do ssania
DRUG25 mg/ 16 h system transdermalny
DRUGNicorette Coolmint
DRUG10 mg/ 16 h system transdermalny

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026