Low-Protein Diet with Low-Protein Foods Versus a LPD Without LP Foods in Patients with Chronic Kidney Disease (CKD)

Last updated: January 27, 2025
Sponsor: Dr. Schär AG / SPA
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Consumption of FLAVIS

Clinical Study ID

NCT05489120
EFFLAVIS
  • Ages > 18
  • All Genders

Study Summary

The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CKD patient stage 3a-5 (<60 ml/min/1.73 m² estimated by CKD-EPI formula) and not ondialysis,

  • With a good nutritional status (i.e., absence of malnutrition according to albumin,pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),

  • Above 1g protein/ kg bw (ideal body weight),

  • LPD-naïve patient,

  • Motivated to LPD introduction (ensure during screening phase patient willingness tomodify diet habits with counselling accurate follow-up),

  • Available to attend the visits planned by the protocol and able to complete the datacollection documents (diet record and self-administered questionnaires),

  • Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11,Code of Public Health, France),

  • Having given their informed written consent regarding its participation to theprotocol.

Exclusion

Exclusion Criteria:

  • Patient for whom dialysis or transplantation is planned/expected within the next 12months

  • Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs,soy, nut),

  • Uncontrolled Diabetes (HbA1C >8.5%),

  • Active cancer (including a 5 years remission period),

  • Psychiatric disorders or inability to follow the protocol,

  • Evidence of any active infectious or uncontrolled inflammatory diseases,

  • Inability to provide blood samples (poor venous capital),

  • Inability to perform correct 24-hours urine collection,

  • Any change of the chronic medication within 1 month before screening,

  • Presence of any significant medical finding or significant history such asuncontrolled systemic diseases that may impact the safety, the interpretation of theresults and/or the participation of the subject in the study according to theopinion of the investigator,

  • Patient with an active implanted medical device

  • Simultaneous participation in another clinical trial or subject still within theexclusion period of a previous clinical trial.

  • Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health,France) are also excluded from the clinical trial.

Study Design

Total Participants: 244
Treatment Group(s): 1
Primary Treatment: Consumption of FLAVIS
Phase:
Study Start date:
November 06, 2022
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Clinique sainte isabelle

    Abbeville, 80100
    France

    Active - Recruiting

  • Cabinet médical du Dr Magnant

    Aix-en-Provence,
    France

    Completed

  • CHU Besançon

    Besançon,
    France

    Active - Recruiting

  • Maison du Rein

    Bordeaux,
    France

    Active - Recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux,
    France

    Active - Recruiting

  • CH Chalon

    Chalon-sur-Saône,
    France

    Active - Recruiting

  • CHU Gabriel Montpied

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Santélys BFC

    Dijon,
    France

    Site Not Available

  • CH Le Mans

    Le Mans,
    France

    Active - Recruiting

  • Hospices Civiles de Lyon

    Lyon,
    France

    Active - Recruiting

  • Hôpital Edouard Heriot

    Lyon,
    France

    Site Not Available

  • Saint Joseph Saint Luc

    Lyon,
    France

    Active - Recruiting

  • Hôpital la conception

    Marseille,
    France

    Active - Recruiting

  • CH Mâcon

    Mâcon,
    France

    Active - Recruiting

  • APHP - Hôpital Necker

    Paris,
    France

    Site Not Available

  • AURA Paris

    Paris,
    France

    Site Not Available

  • Tenon hospital -APHP

    Paris,
    France

    Terminated

  • Hôpital Drôme Nord

    Romans sur Isère,
    France

    Active - Recruiting

  • Nouvel Hôpital Civil

    Strasbourg,
    France

    Site Not Available

  • Calydial

    Vienne,
    France

    Active - Recruiting

  • Hôpital Nord-Ouest

    Villefranche-sur-Saône,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.