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Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life

Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.

NCT01946841•Lactalis

View on ClinicalTrials.gov

Summary

The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week
•Patients aged 18 years
•Written, free and informed consent given by the Patient
•Patient insured under the social security system or equivalent
•Patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion
•Patient in a state of malnutrition
•* defined by the presence of at least 3 out of 5 of the following criteria :
•* weight loss greater than 10% observed in the last six months
•* serum albumin \<35 g / l
•* serum Prealbumin \<300 mg / l
+7 more criteria

Exclusion Criteria

•Patients with a history of intolerance to enteral feeding
•Index Kt/Veq (balanced) \< or = 1.2 or index Kt/Vsp (single pool) \< or = 1.4 according to the method used
•Patients with a disease compromising the short-term (4-6 months) prognosis (cancer or other disease in the terminal phase)
•Pregnant Patient
•Patient with a known allergy to at least one of the following : milk protein, soy, fish
•Patient whose digestive tract is not functional or patient in shock
•Patient protected under guardianship
•Patient in exclusion period after participation in another clinical trial.

Locations (1)

Lactalis

Retiers, France

Key Dates

Start Date

August 1, 2013

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

April 17, 2015

Conditions

Chronic Kidney DiseaseRenal Failure Chronic Requiring HemodialysisSevere MalnutritionToleranceQuality of LifeActivityAppetite and General Nutritional Disorders

Interventions

RealDiet®Renal

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

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