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

Lactalis

Status and phase: Withdrawn; Phase 2

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

Treatments: Dietary Supplement: RealDiet®Renal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01946841

LRD - 2013 - ALENPHED

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

RealDiet®Renal enteral nutrition

Experimental group

Treatment:

Dietary Supplement: RealDiet®Renal