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Study on Nicotinamide for Patients with Acute Kidney Injury

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for acute kidney injury, a condition where the kidneys suddenly stop working properly. The treatment being tested is a supplement called nicotinamide, which is a form of vitamin B3. The study aims to see if nicotinamide can help patients recover kidney function more effectively than the usual care they receive.

Participants in the study will be randomly assigned to one of two groups. One group will receive nicotinamide, while the other group will continue with the standard care they are already receiving. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the nicotinamide or the standard care, ensuring unbiased results.

The main goal of the study is to determine if nicotinamide can lead to complete recovery of kidney function within 21 days. This will be measured by checking the estimated glomerular filtration rate (eGFR), which is a test that shows how well the kidneys are filtering blood. The study will help understand if nicotinamide can be a beneficial addition to the treatment of acute kidney injury.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive nicotinamide (NAM) supplementation, and the other will receive standard care. This process is called randomization and ensures that the study results are unbiased.
Step 2
Medication administration
If you are in the group receiving nicotinamide, you will take the medication orally. The dosage, frequency, and duration of administration will be determined by the study protocol and communicated to you by the study team.
Step 3
Monitoring and assessments
Throughout the study, your kidney function will be closely monitored. This will involve regular assessments to measure your estimated glomerular filtration rate (eGFR), which is a test to check how well your kidneys are working.
Step 4
End of study evaluation
The primary goal of the study is to assess the rate of complete kidney recovery by day 21 after randomization. Complete recovery is defined as achieving an eGFR greater than 60 ml/min if your baseline eGFR is unknown, or returning to your baseline eGFR within a small margin if it is known.

Who can join the trial?

7 criteria

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

Who cannot join the trial?

8 criteria

Patients who have had a kidney transplant cannot participate. A kidney transplant is when a person receives a new kidney from a donor.
Patients who are currently on dialysis are excluded. Dialysis is a treatment that does the work of the kidneys by removing waste and excess fluid from the blood.
Patients with a history of chronic kidney disease stage 4 or 5 are not eligible. Chronic kidney disease is a long-term condition where the kidneys do not work as well as they should.
Patients with severe liver disease cannot take part. Severe liver disease means the liver is not functioning properly.
Patients who are pregnant or breastfeeding are excluded from the study.
Patients with a known allergy to nicotinamide (NAM) cannot participate. Nicotinamide is a form of vitamin B3 used in the study.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Patients with any condition that, in the opinion of the investigator, makes them unsuitable for the study are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
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Marseille, France
Besancon University Hospital Center
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Besançon, France
Centre Hospitalier Universitaire De Montpellier
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Montpellier, France

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Investigated drugs

Nicotinamide (NAM) is a form of vitamin B3 that is being tested in this clinical trial to see if it can help people recover from acute kidney injury. Acute kidney injury is a condition where the kidneys suddenly stop working properly. This trial is looking at whether taking nicotinamide can help the kidneys heal better compared to just receiving the usual care. The goal is to see if nicotinamide can improve kidney function in patients who have not fully recovered after receiving standard treatment for 24 hours.

Nicotinamide

What is already known about the treatment

Nicotinamide – Nicotinamide, also known as NAM, is administered orally or intravenously and is being studied for its potential to help patients recover from acute kidney injury, a condition where the kidneys suddenly stop working properly. Currently, nicotinamide is being evaluated in clinical trials to determine its effectiveness and safety in this context. The main therapeutic indication for nicotinamide in this trial is to aid in the complete recovery of kidney function in patients with severe acute kidney injury who have not improved with standard care. At the molecular level, nicotinamide works by influencing cellular energy production and repair processes, which may help protect and restore kidney cells. It is classified pharmacologically as a form of vitamin B3, which plays a role in various cellular functions.

Investigated diseases

Acute kidney injury – Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or days. It causes a build-up of waste products in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. The condition can affect other organs such as the brain, heart, and lungs. It often occurs in people who are already hospitalized, particularly in critically ill patients who need intensive care. The progression of acute kidney injury can vary, with some individuals experiencing a rapid decline in kidney function, while others may have a more gradual onset. Recovery can occur, but the speed and extent of recovery depend on the underlying cause and the severity of the injury.