Status:
RECRUITING
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
Lead Sponsor:
Dr. Schär AG / SPA
Collaborating Sponsors:
Slb Pharma
Conditions:
Chronic Kidney Disease Stage 3B
Chronic Kidney Disease stage4
Eligibility:
All Genders
18+ years
Phase:
NA
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 li...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT05489120
Start Date
November 6 2022
End Date
March 1 2026
Last Update
January 29 2025
Active Locations (21)
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1
Clinique sainte isabelle
Abbeville, France, 80100
2
Cabinet médical du Dr Magnant
Aix-en-Provence, France
3
CHU Besançon
Besançon, France
4
Maison du Rein
Bordeaux, France