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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01946841
Other study ID # LRD - 2013 - ALENPHED
Secondary ID
Status Withdrawn
Phase Phase 2
First received August 6, 2013
Last updated April 16, 2015
Start date August 2013
Est. completion date July 2014

Study information

Verified date September 2013
Source Lactalis
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
RealDiet®Renal


Locations

Country Name City State
France Lactalis Retiers

Sponsors (2)

Lead Sponsor Collaborator
Lactalis Clinact

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment. 6 months No
Secondary Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment. 6 months No
Secondary Evolution of tolerance of study product during 3 months of enteral nutrition. 3 mois Yes
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