Status:
UNKNOWN
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
Lead Sponsor:
Indigo Therapeutics
Collaborating Sponsors:
BioFortis
Conditions:
End Stage Renal Disease on Dialysis (Diagnosis)
Eligibility:
All Genders
18-100 years
Phase:
NA
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 dis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03807583
Start Date
March 15 2019
End Date
July 1 2020
Last Update
March 19 2019
Active Locations (1)
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1
Hopital Center
Dunkirk, France, 59240