End Stage Renal Disease on Dialysis (Diagnosis)NCT03807583
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
A study testing Aminoven 10% and RENORAL in people with End Stage Renal Disease on Dialysis (Diagnosis), run by Indigo Therapeutics at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis (Diagnosis)
- What is being tested?
- Aminoven 10% and RENORAL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2019to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Center
Dunkirk, 59240
FAHIMA YAHI, +333 28 28 59 00 ext. 6486, Fahima.Yahi-Zidat@ch-dunkerque.fr
About this study
Official title: 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.
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.
- Being tested
- Aminoven 10%, RENORAL
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminoven 10%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.
RENORALDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| AMINOVEN® 10% | Active comparator | 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. Receives: Drug: Aminoven 10% |
| RENORAL® | Experimental | 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. Receives: Dietary Supplement: RENORAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma total amino acid concentration
The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.
Measured: Day 60; Time 240 minutes of the kinetic
Secondary outcomes (17)
Plasma total amino acid concentration
Comparison between the RENORAL® group and the plasma total amino acid concentration control group
Measured: Day 60; Time 240 minutes of kinetics
Plasma total amino acid concentration
Comparison between the RENORAL® group and each AMINOVEN® group and control
Measured: Time 0 minutes, Time 60 minutes and Time 120 minutes of kinetics
Plasma total amino acid concentration
Comparison between the RENORAL® group and each AMINOVEN® group and control
Measured: Day 90; Day 120 and Day 150 at time 240 minutes of kinetics
Protein catabolism
Plasma urea concentration (mmol.L-1) ;
Measured: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Protein catabolism
Plasma creatinine concentration (µmol.L-1);
Measured: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Protein catabolism
Standardized protein catabolism rate (nPCR) (g/kg/day):
- BUN: Blood urea nitrogen is one of the main renal function parameters (mmol/L).
- ID Refers to the interdialytic period in hours.
- ID BUN rise refers to the registered change in blood urea nitrogen during the interdialytic period.
The two nPCR formulas used are:
nPCR Anuric = 0.22 + (0.864 x (ID BUN rise in mg/dL) / (ID hours)) nPCR Total = nPCR Anuric + (Urine urea nitrogen in g x 150) / (ID hours x Weight in kg)
Measured: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Inflammation degree
Comparison between the RENORAL® group and each AMINOVEN® group and control. Evaluated by plasma CRPus concentration (mg.L-1).
Measured: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Nutritional status
Plasma albumin concentration (g.L-1) ;
Measured: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
- Plasma prealbumin concentration (g.L-1) ;
Measured: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
- Plasma ferritin concentration (µg.L-1) ;
Measured: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
- Plasma transferrin concentration (ng.L-1) ;
Measured: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
- Body mass index (BMI) (kg/m2)
Measured: Day 150
Nutritional status
- Body composition by impedance measurement (Body Composition Monitor / Fresenius Medical Care) analyzed by the following parameters: lean mass (LTM) (kg), fat mass (ATM) (kg) and water overload (OH) (L)
Measured: Day 150
Nutritional status
- Total energy intake (average of the 3 food survey days, kcal/day);
Measured: During the week preceding Day 150
Nutritional status
- Protein consumption (average of the 3 food survey days, g/day)
Measured: During the week preceding Day 150
Muscular force
Evaluated by the gripping force by dynamometry (kg)
Measured: Day 150
Acceptability of Renoral®
Self-administered questionnaire
4 questions:
- Overall, do you like this product? minimum score:1 (I don't like); maximum score: 9 (I like a lot)
- How do you find the texture of the product? Score 1: Not at all pleasant Score 2: Somewhat unpleasant Score 3: Somewhat pleasant Score 4: Very pleasant
- What do you think of the practicality of the product? Score 1 - Not practical at all Score 2 - Not very practical Score 3 - Somewhat practical Score 4 - Very practical
- What do you think of the vanilla flavour of the product? Score 1 - Much too pronounced Score 2 - Somewhat pronounced Score 3 - Just the right way Score 4 - Not strong enough Score 5 - Really not pronounced
Measured: Day 60 and Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start15 Mar 2019
- Primary completionJan 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on Dialysis (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indigo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- RAYMOND AZAR, MD, Principal investigator, HOSPITAL CENTER DUNKERQUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807583
- Sponsor's protocol ID
- ID-RCB 2018-00145-50
- Status last verified
- Mar 2019
- First submitted
- 27 Dec 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03807583
- Acronym / sponsor ID
- ID-RCB 2018-00145-50
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indigo TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| AMINOVEN® 10% | Active comparator | Drug: 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. |
| RENORAL® | Experimental | Dietary Supplement: RENORALThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | AMINOVEN® 10% |
| RENORALAfter 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. | Dietary supplement | RENORAL® |
Primary outcome
Plasma total amino acid concentration
Time frame: Day 60; Time 240 minutes of the kinetic
The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.
17 secondary outcomes
Plasma total amino acid concentration
Time frame: Day 60; Time 240 minutes of kinetics
Plasma total amino acid concentration
Time frame: Time 0 minutes, Time 60 minutes and Time 120 minutes of kinetics
Plasma total amino acid concentration
Time frame: Day 90; Day 120 and Day 150 at time 240 minutes of kinetics
Protein catabolism
Time frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Protein catabolism
Time frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Protein catabolism
Time frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Inflammation degree
Time frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Nutritional status
Time frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
Time frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
Time frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
Time frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status
Time frame: Day 150
Nutritional status
Time frame: Day 150
Nutritional status
Time frame: During the week preceding Day 150
Nutritional status
Time frame: During the week preceding Day 150
Muscular force
Time frame: Day 150
Acceptability of Renoral®
Time frame: Day 60 and Day 150
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAYMOND AZAR, MD principal investigator
HOSPITAL CENTER DUNKERQUE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminoven 10% and RENORAL in people with End Stage Renal Disease on Dialysis (Diagnosis), run by Indigo Therapeutics at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAYMOND AZAR, MD (+333 28 28 53 28, Raymond.Azar@ch-dunkerque.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma total amino acid concentration (time frame: Day 60; Time 240 minutes of the kinetic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.