Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis

NCT03807583 | Unknown

• 1 other identifier: ID-RCB 2018-00145-50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of Renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with hemodialysis maintenance.

Conditions

End Stage Renal Disease on Dialysis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Plasma total amino acid concentration

  The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.

  Day 60; Time 240 minutes of the kinetic

Secondary Outcomes (17)

• Plasma total amino acid concentration

  Day 60; Time 240 minutes of kinetics

• Plasma total amino acid concentration

  Time 0 minutes, Time 60 minutes and Time 120 minutes of kinetics

• Plasma total amino acid concentration

  Day 90; Day 120 and Day 150 at time 240 minutes of kinetics

• Protein catabolism

  Day 90; Day 120 and Day 150 at time 0 minutes of kinetics

• Protein catabolism

  Day 90; Day 120 and Day 150 at time 0 minutes of kinetics

Other Outcomes (6)

• Blood pressure (mmHg)

  Day 0 to Day 150 at time 0, 60, 120 and 240 minutes of dialysis

• Blood count

  Day 0 to Day 150 at time 0 minute

• Blood sugar

  Day 0 to Day 150 at time 0 minute

Study Arms (3)

Control group

NO INTERVENTION

AMINOVEN® 10%

ACTIVE COMPARATOR

The AMINOVEN® 10% comparative product is a drug in the form of a 130 mL intravenous infusion solution. This product is composed of amino acids. The product is administered per os during the first hour of dialysis sessions for the duration of the study.

Drug: Aminoven 10%

RENORAL®

EXPERIMENTAL

The product under study RENORAL® is notified to the DGCCRF with the status of food supplement for medical purposes (FSMP) and specific for renal insufficiency. The product is a beverage packaged in 150 mL aluminum cans. It contains a liquid solution of native milk proteins and partially hydrolyzed whey proteins.

Dietary Supplement: RENORAL

Interventions

Aminoven 10% DRUG

After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group: * group A: RENORAL® product * group B: AMINOVEN® 10% product * group C: control group (without intradialytic supplementation) Patients will consume the products and will be followed for 3 months, one visit per month (Day 90, Day 120, Day 150). Protocol visits are included in the patient's course of care.

AMINOVEN® 10%

RENORAL DIETARY_SUPPLEMENT

After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group: * group A: RENORAL® product * group B: AMINOVEN® 10% product * group C: control group (without intradialytic supplementation) Patients will consume the products and will be followed for 3 months, one visit per month ( V3, V4, V5). Protocol visits are included in the patient's course of care.

RENORAL®

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 (limit included),
• Patients treated with hemodialysis for at least 3 months (limit included),
• Patient with normal albuminemia ≥ 35 g/L
• Patient capable and willing to comply with the protocol and willing to give written informed consent,
• Patient affiliated to a social security scheme.

You may not qualify if:

• Patient with a known food allergy or intolerance,
• Patient with alcohol consumption ≥ 20 g/day (equivalent to 2 glasses per day),
• Patient following a specific diet (vegetarian, hypocaloric, restrictive gluten-free diet....) outside the high-protein diet of the patient with terminal renal insufficiency or deviant behavior,
• Pregnant or breastfeeding woman or intending to become pregnant within the next 3 months
• Patient taking vitamin or mineral supplementation for less than one month,
• Patient refusing to give written consent,
• Patient not able to read and understand information, consent or other study related documents (self-administered questionnaires),
• Patient unable to give informed consent,
• Patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship.

Sponsors & Collaborators

• Indigo Therapeutics: lead
• BioFortis: collaborator

Study Sites (1)

Hopital Center

Dunkirk, 59240, France

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• RAYMOND AZAR, MD

  HOSPITAL CENTER DUNKERQUE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAYMOND AZAR, MD

CONTACT

+333 28 28 53 28; Raymond.Azar@ch-dunkerque.fr

FAHIMA YAHI

CONTACT

+333 28 28 59 00; Fahima.Yahi-Zidat@ch-dunkerque.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 17, 2019
• Study Start: March 15, 2019
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)