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

NCT ID: NCT03807583

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2020-07-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

AMINOVEN® 10%

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.

Group Type: ACTIVE_COMPARATOR

Aminoven 10%

Intervention Type: 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.

RENORAL®

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.

Group Type: EXPERIMENTAL

RENORAL

Intervention Type: 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.

Interventions

Aminoven 10%

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.

Intervention Type: DRUG

RENORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 participating in another clinical study or in a period of exclusion from a previous clinical study;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Indigo Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

RAYMOND AZAR, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL CENTER DUNKERQUE

Locations

Hopital Center

Dunkirk, , France

Site Status: RECRUITING

Countries

France

Central Contacts

RAYMOND AZAR, MD

Role: CONTACT

Raymond.Azar@ch-dunkerque.fr

+333 28 28 53 28

FAHIMA YAHI

Role: CONTACT

Fahima.Yahi-Zidat@ch-dunkerque.fr

+333 28 28 59 00 ext. 6486

Facility Contacts

FAHIMA YAHI

Role: primary

Fahima.Yahi-Zidat@ch-dunkerque.fr

+333 28 28 59 00 ext. 6486

Other Identifiers

ID-RCB 2018-00145-50

Identifier Type: -

Identifier Source: org_study_id