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

NCT ID: NCT01946841

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-07-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RealDiet®Renal enteral nutrition

Group Type: EXPERIMENTAL

RealDiet®Renal

Intervention Type: DIETARY_SUPPLEMENT

Interventions

RealDiet®Renal

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinact

OTHER

Sponsor Role: collaborator

Lactalis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lactalis

Retiers, , France

Countries

France

Other Identifiers

LRD - 2013 - ALENPHED

Identifier Type: -

Identifier Source: org_study_id