Trials / Unknown
UnknownNCT03807583
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
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.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Indigo Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-03-15
- Primary completion
- 2020-01-01
- Completion
- 2020-07-01
- First posted
- 2019-01-17
- Last updated
- 2019-03-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03807583. Inclusion in this directory is not an endorsement.