Back to resultsSpecific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life (AL-EN-PHED)
Primary Purpose
Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition
Status
Withdrawn
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
RealDiet®Renal
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Hemodialysis, Severe malnutrition, Enteral nutrition
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.
Sites / Locations
- Lactalis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RealDiet®Renal enteral nutrition
Arm Description
Outcomes
Primary Outcome Measures
Evolution of serum prealbumin and albumin.
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.
Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.
Evolution of tolerance of study product during 3 months of enteral nutrition.
Full Information
NCT ID
NCT01946841
First Posted
August 6, 2013
Last Updated
April 16, 2015
Sponsor
Lactalis
Collaborators
Clinact
1. Study Identification
Unique Protocol Identification Number
NCT01946841
Brief Title
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
Acronym
AL-EN-PHED
Official Title
Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No Patient recruitment
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lactalis
Collaborators
Clinact
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance, Quality of Life, Activity, Appetite and General Nutritional Disorders
Keywords
Chronic kidney disease, Hemodialysis, Severe malnutrition, Enteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RealDiet®Renal enteral nutrition
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
RealDiet®Renal
Primary Outcome Measure Information:
Title
Evolution of serum prealbumin and albumin.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment.
Time Frame
6 months
Title
Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.
Time Frame
6 months
Title
Evolution of tolerance of study product during 3 months of enteral nutrition.
Time Frame
3 mois
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Lactalis
City
Retiers
ZIP/Postal Code
35240
Country
France
12. IPD Sharing Statement
Learn more about this trial
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
We'll reach out to this number within 24 hrs