NCT05489120 Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
| NCT ID | NCT05489120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Schär AG / SPA |
| Condition | Chronic Kidney Disease Stage 3B |
| Study Type | INTERVENTIONAL |
| Enrollment | 244 participants |
| Start Date | 2022-11-06 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 244 participants in total. It began in 2022-11-06 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Laetitia Koppe, Dr
STUDY DIRECTOR
HCL
Frequently Asked Questions
Who can join the NCT05489120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Disease Stage 3B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05489120 currently recruiting?
Yes, NCT05489120 is actively recruiting participants. Contact the research team at v.dumay@slbpharma.com for enrollment information.
Where is the NCT05489120 trial being conducted?
This trial is being conducted at Abbeville, France, Aix-en-Provence, France, Besançon, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT05489120 clinical trial?
NCT05489120 is sponsored by Dr. Schär AG / SPA. The principal investigator is Laetitia Koppe, Dr at HCL. The trial plans to enroll 244 participants.
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