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NCT Number: NCT03636932

RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine

Chronic Kidney Disease (CKD) is a known risk factor of cardiovascular morbidity and mortality.

In CKD, decline of renal function results in the accumulation of uremic toxins in blood and tissue, such as Indoxyl Sulfate (IS). IS plasma level is predictive of mortality and cardiovascular disease (CVD). Patients with CKD have increased oxidative stress and circulating tissue factor (TF) levels. In vitro, IS induces an inflammatory, pro-oxidative and pro-coagulant phenotype on endothelial cells and activates TF. N-acetylcysteine (NAC) protects endothelial cells from the effects of IS. NAC reduces oxidative stress and production of activated TF. A prospective study evaluating an oral NAC treatment versus placebo in chronic hemodialysis patients showed a better cardiovascular outcome but the physiopathology was unclear.

The hypothesis is that NAC reduces cardiovascular risk by its effect on uremic toxin-induced pro-coagulant TF production.

The primary objective is to compare the effect of NAC intravenously administered at each dialysis session (2gram on 3 dialysis sessions per week) to placebo on circulating TF levels in patients with CKD on chronic hemodialysis after 4 weeks of treatment. The objective is to show a 33% decrease in circulating tissue factor (TF) levels in the NAC group compared to the control group.

It is a randomized, double-blind, placebo-controlled crossover trial that includes chronic hemodialysis patients from La Conception Hospital (AP-HM) in Marseilles, France. This is an interventional biomedical research project.

20 patients will be included in each group and will receive during 4 weeks intravenous injection.

This study will give a pathophysiological rationale for the use of NAC to reduce thrombotic and cardiovascular risk in patients with CKD. This step will provide the rationale for a clinical trial to reduce the occurrence of major cardiovascular events with IV NAC in hemodialysis (HD) patients.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis patients regardless of the etiology of their renal insufficiency for more than 3 months on a cycle of 3 sessions per week
  • Hemodialysis patients at least 4 hours per dialysis session
  • Patients with a weight of more than 40 kilogram
  • Patients capable of giving informed consent, agreeing to participate in the study and having signed a consent
  • Patient able to understand a written questionnaire

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 (scleroderma for example)
  • Chronic progressive infection that may affect their thrombotic risk
  • Patients under 40 kilogram
  • Patient taking oral anticoagulants
  • Patient with a known allergy to the active molecule or to any of its excipients

Treatment and study plan

N-acetylcysteine (NAC)

Drug

Intravenous injection of 2 gram of N-acetylcysteine (NAC) during 4 weeks, 3 times per week during the first three hours of dialysis.

Placebo

Drug

Intravenous injection of 2 gram of Placebo during 4 weeks, 3 times per week during the first three hours of dialysis.

Blood sample

Biological

Circulating tissue factor assay

Primary outcomes

  1. compare the effect of N-acetylcysteine (NAC) intravenously administered

    Time frame: 12 months

    show a 33% decrease in circulating tissue factor levels in the N-acetylcysteine (NAC) group

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: RENACTIF

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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