NICOTINAMIDE for Acute kidney injury

Inclusion criteria

• {"criterion_text":"- Admitted to an adult intensive care unit of nephrology or Nephrology department"}
• {"criterion_text":"- Age 18 years or more"}
• {"criterion_text":"- Persistent acute kidney injury stage 2 or 3 in KDIGO classification despite 24h with standard care to treat pre-renal acute kidney injury according Acute Disease Quality Initiative (ADQI) workgroup"}
• {"criterion_text":"- Suspected acute tubular necrosis as primary cause of acute kidney injury"}
• {"criterion_text":"- Free from mechanical ventilation; hemodynamic support and non-invasive ventilation are allowed"}
• {"criterion_text":"- Subject affiliated to or beneficiary of a social security system"}
• {"criterion_text":"- Subject having signed written informed consent"}

Exclusion criteria

• {"criterion_text":"- Acute kidney injury stage 1 (due to a very high rate of renal recovery and no potential impact of nicotinamide) in accordance with the 2019 reviews"}
• {"criterion_text":"- Moribund status (defined by the expectation of death in less than three months)"}
• {"criterion_text":"- Liver failure (to prevent NAM liver toxicity) according to the definition in MODS above)"}
• {"criterion_text":"- Thrombocytopenia < 50 G/L (which might occur in patients requiring dialysis and receiving NAM)"}
• {"criterion_text":"- Known allergy to NAM"}
• {"criterion_text":"- Taking supplemental nicotinamide or niacin (other nicotinamide supplements to be ceased 4 weeks prior to study randomization)"}
• {"criterion_text":"- Ongoing participation in a concurrent interventional study"}
• {"criterion_text":"- Pregnancy or breastfeeding and all other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without content, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations"}
• {"criterion_text":"- Severe cognitive or psychiatric disorders"}
• {"criterion_text":"- Inability to provide informed consent, or unwillingness to participate in the study"}
• {"criterion_text":"- Patients with limited French proficiency"}
• {"criterion_text":"- Acute kidney disease (AKD) defined by AKI persisting more than 7 days and less than 3 months according ADQI workgroup"}
• {"criterion_text":"- Patients not in capacity to consent and without legal representatives present to receive information and consent for the participation of the patient"}
• {"criterion_text":"- End stage renal disease with chronic renal replacement therapy (intermittent hemodialysis or peritoneal dialysis)"}
• {"criterion_text":"- Chronic kidney disease with glomerular filtration rate ≤ 15 ml/min/1.73m2"}
• {"criterion_text":"- History of kidney transplantation"}
• {"criterion_text":"- Mechanical ventilation"}
• {"criterion_text":"- Conditions requiring vitamin B3 supplementation: Nutritional deficiency or alcohol abuse."}
• {"criterion_text":"- Multiple organ dysfunction syndrome (MODS) based on modified Surviving Sepsis Campaign criteria (21). Patients with two or more organ dysfunctions other than kidney dysfunction will be categorized as having MODS. Respiratory dysfunction is defined as a PaO2/FiO2 ratio <200 and requiring mechanical ventilation. Shock status is defined as hypotension (systolic blood pressure <90 mm Hg or mean arterial pressure <70 mm Hg) that requires the use of norepinephrine > 15 μg/min. Hepatic dysfunction is defined as serum bilirubin level >2 mg/dL. Hematologic dysfunction is defined as a blood platelet count <100,000/μL. Coagulopathy is defined as an international normalized ratio >1.5. Metabolic dysfunction is defined as a serum lactate level >2 mmol/L."}
• {"criterion_text":"- Primary cause of AKI other than suspected ATN (renal obstruction, glomerulonephritis, immuno-allergic nephritis)."}

Primary endpoints

• {"endpoint_text":"- rate of complete renal recovery (success) assessed at day + 21 post-randomization. The complete renal recovery, (success) will be defined from the estimated glomerular filtration rate (eGFR): - if baseline eGFR is unknown; an eGFR >60ml/min (at day+21 according to the mention above) - if baseline eGFR is available; by the return to baseline eGFR +/- 3.","definition_or_measurement_approach":"Complete renal recovery assessed at day 21 post-randomization using estimated glomerular filtration rate (eGFR): if baseline eGFR is unknown then eGFR > 60 ml/min at day+21; if baseline eGFR is available then return to baseline eGFR ± 3."}

France

Earliest CTIS Part Ii Submission Date

11-04-2025

Latest Decision Or Authorization Date

28-05-2025

Processing Time Days

47

Number Of Sites

10

Number Of Participants

306

Primary sponsor

Full Name

Assistance Publique Hopitaux De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France