Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life (AL-EN-PHED)

This study has been withdrawn prior to enrollment.
(No Patient recruitment)
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 6, 2013
Last updated: April 16, 2015
Last verified: September 2013

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.

Condition Intervention Phase
Chronic Kidney Disease
Renal Failure Chronic Requiring Hemodialysis
Severe Malnutrition
Quality of Life
Appetite and General Nutritional Disorders
Dietary Supplement: RealDiet®Renal
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.

Resource links provided by NLM:

Further study details as provided by Lactalis:

Primary Outcome Measures:
  • Evolution of serum prealbumin and albumin. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evolution of tolerance of study product during 3 months of enteral nutrition. [ Time Frame: 3 mois ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: August 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RealDiet®Renal enteral nutrition Dietary Supplement: RealDiet®Renal


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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


  • 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01946841

Retiers, France, 35240
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Lactalis
ClinicalTrials.gov Identifier: NCT01946841     History of Changes
Other Study ID Numbers: LRD - 2013 - ALENPHED
Study First Received: August 6, 2013
Last Updated: April 16, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Lactalis:
Chronic kidney disease
Severe malnutrition
Enteral nutrition

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Nutrition Disorders
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 06, 2015