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

Phase 2

Withdrawn

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

• Registration Number: NCT01946841
• Lead Sponsor: Lactalis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-06
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lactalis; 🇫🇷 Retiers, France