Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)

NCT05489120 | Recruiting DMC

• 1 other identifier: EFFLAVIS
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 21

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.

Conditions

Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5; Chronic Kidney Disease Stage 3A

Keywords

low-protein diet; low-protein foods; FLAVIS; compliance; effectiveness; safety

Outcome Measures

Primary Outcomes (1)

• Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)

  Maroni formula : (Measurement of urea in urine + (\[patient weight\]\*0.031))\*6.25

  12 month

Secondary Outcomes (15)

• Protein intake during the 12 months follow-up

  1 month, 3 month, 6 month and 9 month

• Dietary adherence

  baseline, 1 month, 3 month, 6 month and 12 month

• Dietary compliance for products under study

  monthly up to 12 months

• Effects of the LPD on BMI

  baseline, 1 month, 3 month, 6 month and 12 month

• Effects of the LPD on weight

  baseline, 1 month, 3 month, 6 month and 12 month

Study Arms (2)

COMPARATOR

NO INTERVENTION

Follow-up of the CKD patient according to current practice i.e. low protein diet.

FLAVIS

EXPERIMENTAL

Follow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS).

Other: Consumption of FLAVIS

Interventions

Consumption of FLAVIS OTHER

Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.

FLAVIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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,
• 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
• 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.

Sponsors & Collaborators

• Dr. Schär AG / SPA: lead
• Slb Pharma: collaborator

Study Sites (21)

Clinique sainte isabelle

Abbeville, 80100, France

RECRUITING

Cabinet médical du Dr Magnant

Aix-en-Provence, France

COMPLETED

CHU Besançon

Besançon, France

RECRUITING

Maison du Rein

Bordeaux, France

RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

RECRUITING

CH Chalon

Chalon-sur-Saône, France

RECRUITING

CHU Gabriel Montpied

Clermont-Ferrand, France

RECRUITING

Santélys BFC

Dijon, France

WITHDRAWN

CH Le Mans

Le Mans, France

RECRUITING

Hospices Civiles de Lyon

Lyon, France

RECRUITING

Hôpital Edouard Heriot

Lyon, France

WITHDRAWN

Saint Joseph Saint Luc

Lyon, France

RECRUITING

Hôpital la conception

Marseille, France

RECRUITING

CH Mâcon

Mâcon, France

RECRUITING

APHP - Hôpital Necker

Paris, France

NOT YET RECRUITING

AURA Paris

Paris, France

WITHDRAWN

Tenon hospital -APHP

Paris, France

TERMINATED

Hôpital Drôme Nord

Romans-sur-Isère, France

RECRUITING

Nouvel Hôpital Civil

Strasbourg, France

NOT YET RECRUITING

Calydial

Vienne, France

RECRUITING

Hôpital Nord-Ouest

Villefranche-sur-Saône, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Patient Compliance

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Laetitia Koppe, Dr

  HCL

  STUDY DIRECTOR

Central Study Contacts

Vinciane Dumay

CONTACT

0756917356; v.dumay@slbpharma.com

Ophélie Flageul

CONTACT

0299121962; o.flageul@slbpharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: November 6, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)