Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients

Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition

Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency
• Intervention / Treatment: Dietary supplement: oral nutritional supplementation; Dietary supplement: intradialytic parenteral nutrition

Detailed Description

The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Privé La Louvière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with renal failure, on hemodialysis for at least 12 months;
• Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);
• Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;
• Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:
• Patient who signed an informed consent form to participate in the study

Exclusion Criteria:

• Known allergy to PEPA® ;
• Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
• Patient with a chronic infection in progress;
• Patient with life expectancy <6 months according to the investigator;
• Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);
• Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding;
• Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
• Patient not benefiting from a social security scheme.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Membrane PEPA®; Patient will use the membrane PEPA® for the dialysis	Dietary supplement: oral nutritional supplementation; Adjunction of oral nutritional supplementation
ACTIVE_COMPARATOR: Standard membrane of dialysis; Patient will use a standard membrane for the dialysis	Dietary supplement: intradialytic parenteral nutrition; Adjunction of intradialytic parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the nutritional status	The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of nutritional assessment	Evolution of the percentage of weight loss (in Kg)	Month 6
Appearance of adverse events	Incidence and characteristics of adverse events / effects	Month 6
Measure of the Quality of life	Evolution of the quality of life, evaluated by the EORTC QLQ-C30 questionnaire of the quality of life with 28 questions with 4 possible answers from "not at all" to "a lot of"	Month 6

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2020
• Primary Completion (ACTUAL): June 4, 2021
• Study Completion (ACTUAL): June 4, 2021

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (ACTUAL): June 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 2020-A01267-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No