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.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01946841

Acronym

AL-EN-PHED

Enrollment

Registered

2013-09-20

Start date

2013-08-31

Completion date

2014-07-31

Last updated

2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activity, Appetite and General Nutritional Disorders, Chronic Kidney Disease, Quality of Life, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance

Keywords

Chronic kidney disease, Hemodialysis, Severe malnutrition, Enteral nutrition

Brief 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.

Interventions

DIETARY_SUPPLEMENTRealDiet®Renal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 * BMI \<20 * NPNA \<1 g / kg / day for 2 consecutive months and * presenting * food intake \<20 kcal / kg / day or * failure of other nutritional care methods, namely, oral nutritional supplements and / or peridialytic parenteral nutrition, or total parenteral nutrition * lack of compliance after one month, to the nutritional care methods mentioned above. • Patients for whom the decision to prescribe enteral feeding was previously taken

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.

Design outcomes

Primary

Measure	Time frame	Description
Evolution of serum prealbumin and albumin.	6 months	Evaluate during 3 months specific enteral nutrition (SEN) treatment, and 3 months after treatment interruption, the effects of the study product on the evolution of serum prealbumin and albumin.

Secondary

Measure	Time frame
Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment.	6 months
Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.	6 months
Evolution of tolerance of study product during 3 months of enteral nutrition.	3 mois

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026