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

NCT03807583 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-03-19

No results posted yet for this study

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)

Interventions

DRUG

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • Indigo Therapeutics

    lead INDUSTRY

Principal Investigators

  • RAYMOND AZAR, MD · HOSPITAL CENTER DUNKERQUE

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2020-01-31
Completion
2020-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03807583 on ClinicalTrials.gov