NCT01946841

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

August 6, 2013

Last Update Submit

April 16, 2015

Conditions

Chronic Kidney DiseaseRenal Failure Chronic Requiring HemodialysisSevere MalnutritionToleranceQuality of LifeActivityAppetite and General Nutritional Disorders

Keywords

Chronic kidney diseaseHemodialysisSevere malnutritionEnteral nutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

RealDiet®Renal enteral nutrition

EXPERIMENTAL
Dietary Supplement: RealDiet®Renal

Interventions

RealDiet®RenalDIETARY_SUPPLEMENT
RealDiet®Renal enteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lactalis

Retiers, 35240, France

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicMalnutritionMotor Activity

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesBehavior
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2013

First Posted

September 20, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

April 17, 2015

Record last verified: 2013-09

Locations

FR(1)