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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Lactalis
Sponsor:
Collaborator:
Clinact
Information provided by (Responsible Party):
Lactalis
ClinicalTrials.gov Identifier:
NCT01946841
First received: August 6, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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
Tolerance
Quality of Life
Activity
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 ]

Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RealDiet®Renal enteral nutrition Dietary Supplement: RealDiet®Renal

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Jacqueline Brasy +33 299475084 jacqueline.brasy@lactalis.fr
Contact: Pascale Le Ruyet +33 299475099 pascale.leruyet@lactalis.fr

Locations
France
Lactalis Recruiting
Retiers, France, 35240
Contact: Jacqueline Brasy    +33299475084    jacqueline.brasy@lactalis.fr   
Sponsors and Collaborators
Lactalis
Clinact
  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: September 17, 2013
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
Hemodialysis
Severe malnutrition
Enteral nutrition

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

ClinicalTrials.gov processed this record on November 24, 2014