RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine : A Randomized, Double-blind, Placebo-controlled, Cross-over Trial

Phase 1

• Conditions: Chronic Kidney Disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-003232-80-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adult subjects of both sexes aged 18 years and over
Affiliated subjects or beneficiaries of a social security scheme
Hemodialysis patients regardless of the etiology of their renal insufficiency for more than three months on a cycle of three sessions per week
Hemodialysis patients at least four hours per dialysis session
Patients with a weight of more than 40kg
Subjects capable of giving informed consent, agreeing to participate in the study and having signed a consent
Patient able to understand a written questionnaire
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Pregnant or lactating women
Persons deprived of their liberty or hospitalized without consent
Majors under legal protection or unable to express their consent Possibility of recovery of renal function
Chronic progressive infection that may affect their thrombotic risk: progressive neoplasia, anticoagulant treatment prescribed for less than 1 month
Patients with a weight under 40 kg
Patient not able to express his consent
Patient taking AVK-type oral anticoagulants outside anticoagulation during the session.
Patient with a known allergy to the active molecule or an excipient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified