Acute Renal InsufficiencyNI-AKINCT07203131
Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care (NI-AKI)
A study testing Urine sample and Phone call at day 28 in people with Acute Renal Insufficiency and NAD, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Among all patients admitted to intensive care, it is estimated that more than half of them are exposed during their stay to acute renal failure (ARF). Impacting the vital prognosis to short term, the occurrence of renal failure is not without consequences in intensive care survivors, presenting an increased risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Insufficiency, NAD
- What is being tested?
- Urine sample and Phone call at day 28
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2025to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female aged over 18,
- Patient admitted to intensive care for a reason with a high risk of ARI: shock, sepsis, cardio-circulatory arrest, post-operative unscheduled surgery, post-operative cardiac surgery,
- Patient with normal renal function on admission,
- Patient affiliated to or beneficiary of a social security scheme,
- Patient having been informed and having given his/her free, informed and written consent
Who cannot join
- Minor patient,
- History of chronic kidney disease,
- History of kidney transplant,
- Admission for a reason with a low risk of ARI (neuroresuscitation, voluntary drug intoxication with anxiolytics - antidepressants - psychotropic drugs),
- Acute non-infectious respiratory failure, (scheduled surgery other than cardiac surgery)
- Patient hospitalized without consent,
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- Patient in a period of exclusion due to another research still in progress at the time of inclusion,
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
- Pregnant, breastfeeding or parturient woman.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé de l'Ouest Parisien
Trappes, 78190
Matthieu JAMME, Dr, mat.jamme@gmail.com
About this study
Official title: Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care
Among all patients admitted to intensive care, it is estimated that more than half of them are exposed during their stay to acute renal failure (ARF). Impacting the vital prognosis to short term, the occurrence of renal failure is not without consequences in intensive care survivors, presenting an increased risk of death mainly mediated by an excess risk with regard to chronic kidney disease and/or certain cardiovascular pathologies.
Malnutrition, particularly vitamin deficiency, has already been reported as a risk factor for AKI. Studies on two models (animal and human) have recently highlighted the importance of NAD+ production failure in the onset of renal failure.
Read more
NAD+ synthesis can be done from tryptophan or via a salvage pathway from vitamin PP.
In a phase 2 study in patients undergoing cardiac surgery, vitamin B3 supplementation was accompanied by a reduction in the occurrence of AKI and a limitation of the duration / intensity of renal dysfunction.
This innovative research aims to identify an alteration in the metabolic pathway of NAD+ production as a risk factor for AKI in intensive care patients. This would be the first study to address this issue in this specific population.
The main objective of this research is to describe the association between the urinary Quinolinate/Tryptophan ratio on admission and the occurrence of acute renal failure in patients admitted to intensive care unit.
- Conditions
- Acute Renal Insufficiency, NAD
- Being tested
- Urine sample, Phone call at day 28
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sampleDiagnostic test
5 mL of urine when the patient is admitted in intensive care To look for possible acute renal failure in the patient
Phone call at day 28Other
It will allow the following information to be collected:
- Post-resuscitation monitoring and length of hospitalization,
- Vital status,
- Collection of adverse events,
- Concomitant treatments.
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted to intensive care for a high-risk reason of ARI | Experimental | Patient admitted to intensive care for a high-risk reason of ARI : Shock, Sepsis, Cardiovascular arrest, Post-operative unscheduled surgery, Post-operative cardiac surgery Receives: Diagnostic Test: Urine sample; Other: Phone call at day 28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute renal insufficiency
- An increase in creatinine ≥ 0.3 mg/dL (26.5 μmol/L) within 48 hours
- Or an increase in creatinine ≥ 1.5 times the baseline value
- Or a urine volume < 0.5 mL/kg/h over a 6-hour period
- Urinary Quinolinate/Tryptophan (Q/T) ratio on admission
Measured: 2 days
Secondary outcomes (4)
ARI Features : severity of ARI
- grad 1 : creatinine between 1.5 and 1.9 times the baseline value OR increase ≥ 0.3 mg/dL (26.5 μmol/l) and urine < 0.5 mL/kg/h over a period of 6h to 12h
- grad 2 : creatinine between 2.0 and 2.9 times the base value and urine < 0.5 mL/kg/h over a duration ≥12
- grad 3 : creatinine greater than or equal to 3.0 times the baseline value OR increase ≥ 4.0 mg/dL (353.6 μmol/L) OR use of extra-renal purification OR patients under 18 years of age with decrease in creatinine clearance < 35 mL/min per 1.73 m² and urine < 0.3 mL/kg/h over a duration of ≥24h OR anuria over a duration of ≥12h
Measured: 12 hours
Duration or ARI
Duration in days of ARI
Measured: between 1 day and 28 days
Cardiovascular complications
- evolution of the troponin level between D1 and D7,
- Use of mechanical ventilation and duration,
- Evolution of the SOFA score between D1 and D7
Measured: between day 1 and day 7
Patient follow-up
Mortality within 28 days of admission to intensive care, NI-AKI
- Number of days alive outside intensive care within 28 days of admission to intensive care,
- Number of days alive not hospitalized within 28 days of admission to intensive care.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start17 Mar 2025
- Primary completion5 Nov 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203131
- Sponsor's protocol ID
- 2023-A01709-36
- Acronym
- NI-AKI
- Status last verified
- Sep 2025
- First submitted
- 26 May 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care
- ClinicalTrials.gov ID
- NCT07203131
- Acronym / sponsor ID
- NI-AKI / 2023-A01709-36
- Conditions
- Acute Renal Insufficiency, NAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 2 Oct 2025 (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.
Among all patients admitted to intensive care, it is estimated that more than half of them are exposed during their stay to acute renal failure (ARF). Impacting the vital prognosis to short term, the occurrence of renal failure is not without consequences in intensive care survivors, presenting an increased risk of death mainly mediated by an excess risk with regard to chronic kidney disease and/or certain cardiovascular pathologies.
Malnutrition, particularly vitamin deficiency, has already been reported as a risk factor for AKI. Studies on two models (animal and human) have recently highlighted the importance of NAD+ production failure in the onset of renal failure.
NAD+ synthesis can be done from tryptophan or via a salvage pathway from vitamin PP.
In a phase 2 study in patients undergoing cardiac surgery, vitamin B3 supplementation was accompanied by a reduction in the occurrence of AKI and a limitation of the duration / intensity of renal dysfunction.
This innovative research aims to identify an alteration in the metabolic pathway of NAD+ production as a risk factor for AKI in intensive care patients. This would be the first study to address this issue in this specific population.
The main objective of this research is to describe the association between the urinary Quinolinate/Tryptophan ratio on admission and the occurrence of acute renal failure in patients admitted to intensive care unit.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient admitted to intensive care for a high-risk reason of ARI | Experimental | Diagnostic Test: Urine sample, Other: Phone call at day 28Patient admitted to intensive care for a high-risk reason of ARI : Shock, Sepsis, Cardiovascular arrest, Post-operative unscheduled surgery, Post-operative cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female aged over 18,
- Patient admitted to intensive care for a reason with a high risk of ARI: shock, sepsis, cardio-circulatory arrest, post-operative unscheduled surgery, post-operative cardiac surgery,
- Patient with normal renal function on admission,
- Patient affiliated to or beneficiary of a social security scheme,
- Patient having been informed and having given his/her free, informed and written consent
Key exclusion criteria (9 listed)
- Minor patient,
- History of chronic kidney disease,
- History of kidney transplant,
- Admission for a reason with a low risk of ARI (neuroresuscitation, voluntary drug intoxication with anxiolytics - antidepressants - psychotropic drugs),
- Acute non-infectious respiratory failure, (scheduled surgery other than cardiac surgery)
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 |
|---|---|---|
| Urine sample5 mL of urine when the patient is admitted in intensive care To look for possible acute renal failure in the patient | Diagnostic test | Patient admitted to intensive care for a high-risk reason of ARI |
| Phone call at day 28It will allow the following information to be collected: * Post-resuscitation monitoring and length of hospitalization, * Vital status, * Collection of adverse events, * Concomitant treatments. | Other | Patient admitted to intensive care for a high-risk reason of ARI |
Primary outcome
Acute renal insufficiency
Time frame: 2 days
* An increase in creatinine ≥ 0.3 mg/dL (26.5 μmol/L) within 48 hours * Or an increase in creatinine ≥ 1.5 times the baseline value * Or a urine volume < 0.5 mL/kg/h over a 6-hour period * Urinary Quinolinate/Tryptophan (Q/T) ratio on admission
4 secondary outcomes
ARI Features : severity of ARI
Time frame: 12 hours
Duration or ARI
Time frame: between 1 day and 28 days
Cardiovascular complications
Time frame: between day 1 and day 7
Patient follow-up
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine sample and Phone call at day 28 in people with Acute Renal Insufficiency and NAD, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 9 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu JAMME, Dr (00336 87 64 61 12, mat.jamme@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute renal insufficiency (time frame: 2 days). 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 2 Oct 2025.