Informations générales (source: ClinicalTrials.gov)
Prospective, Monocentric, Open-label, Randomized Study Comparing Intradialytic Plasma Kinetics of Amino Acids After Administration Per os of Renoral® and Intravenous Administration of Amino Acids.
Interventional
N/A
Indigo Therapeutics (Voir sur ClinicalTrials)
mars 2019
juillet 2020
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hopital Center - 59240 - Dunkerque - France | FAHIMA YAHI | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.