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Compares treatment options for Chronic Kidney Disease Stage 3B
Official title Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
ClinicalTrials.gov ID: NCT05489120
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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),
You likely can't join if
- 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,
See the full eligibility 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.
- 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...
- 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 people (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Abbeville, France
- Aix-en-Provence, France
- Besançon, France
- Bordeaux, France
- Chalon-sur-Saône, France
- Clermont-Ferrand, France
- Dijon, France
- Le Mans, France
- Lyon, France
- Marseille, France
- Mâcon, France
- Paris, France
- Romans-sur-Isère, France
- Strasbourg, France
- Vienne, France
- Villefranche-sur-Saône, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abbeville, France; Aix-en-Provence, France; Besançon, France; Bordeaux, France; Chalon-sur-Saône, France; Clermont-Ferrand, France and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.