Phase
Condition
N/ATreatment
Consumption of FLAVIS
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Clinique sainte isabelle
Abbeville, 80100
FranceActive - Recruiting
Cabinet médical du Dr Magnant
Aix-en-Provence,
FranceCompleted
CHU Besançon
Besançon,
FranceActive - Recruiting
Maison du Rein
Bordeaux,
FranceActive - Recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux,
FranceActive - Recruiting
CH Chalon
Chalon-sur-Saône,
FranceActive - Recruiting
CHU Gabriel Montpied
Clermont-Ferrand,
FranceActive - Recruiting
Santélys BFC
Dijon,
FranceSite Not Available
CH Le Mans
Le Mans,
FranceActive - Recruiting
Hospices Civiles de Lyon
Lyon,
FranceActive - Recruiting
Hôpital Edouard Heriot
Lyon,
FranceSite Not Available
Saint Joseph Saint Luc
Lyon,
FranceActive - Recruiting
Hôpital la conception
Marseille,
FranceActive - Recruiting
CH Mâcon
Mâcon,
FranceActive - Recruiting
APHP - Hôpital Necker
Paris,
FranceSite Not Available
AURA Paris
Paris,
FranceSite Not Available
Tenon hospital -APHP
Paris,
FranceTerminated
Hôpital Drôme Nord
Romans sur Isère,
FranceActive - Recruiting
Nouvel Hôpital Civil
Strasbourg,
FranceSite Not Available
Calydial
Vienne,
FranceActive - Recruiting
Hôpital Nord-Ouest
Villefranche-sur-Saône,
FranceActive - Recruiting
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