This clinical trial is focused on studying a condition called Hemolytic Uremic Syndrome, which is associated with an infection caused by a type of bacteria known as Shiga toxin-producing Escherichia coli. This condition can lead to serious kidney problems, especially in children. The study is testing a treatment called INM004, also known as Shiga antitoxin, which is designed to target and neutralize the harmful effects of the Shiga toxin produced by the bacteria. The treatment is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream.
The purpose of the study is to evaluate how effective INM004 is in improving kidney function in children affected by this condition. Participants in the study will receive either the INM004 treatment or a placebo, which is a solution that looks like the treatment but does not contain the active substance. The study will monitor the participants over a period to see how their kidney function recovers, particularly focusing on the time it takes for their kidneys to start working properly again without the need for dialysis, a process that helps clean the blood when the kidneys are not functioning well.
Throughout the study, researchers will also look at other important outcomes, such as the overall recovery of kidney function after three months, the need for extended dialysis, and the general health of the participants. The study aims to provide valuable information on whether INM004 can be a beneficial treatment for children suffering from Hemolytic Uremic Syndrome due to Shiga toxin-producing Escherichia coli.



Belgium
France
Germany
Ireland
Italy
Romania
Spain
The Netherlands