Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05489120
Eligibility Criteria:
Inclusion Criteria:
* CKD patient stage 3a-5 (\<60 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,
* 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 to modify diet habits with counselling accurate follow-up),
* Available to attend the visits planned by the protocol and able to complete the data collection 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 the protocol.
Exclusion Criteria:
* Patient for whom dialysis or transplantation is planned/expected within the next 12 months
* 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 as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
* Patient with an active implanted medical device
* Simultaneous participation in another clinical trial or subject still within the exclusion 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05489120
Study Brief:
Protocol Section:
NCT05489120