In short
Clinical trials investigating Mannitol are studying how it performs in different patient groups, mainly in kidney transplantation, traumatic brain injury, colonoscopy preparation, bronchiectasis, and newborn brain injury. These trials look at outcomes such as safety, kidney function, bowel cleansing, breathing symptoms, and long-term recovery.
Key points
- Mannitol clinical trials in the provided data focus on several patient groups, including kidney transplant patients, people with traumatic brain injury, adults preparing for colonoscopy, patients with bronchiectasia, and newborns with hypoxic-ischemic brain injury. Most of the studies are Phase 3 trials, with one Phase 2 study in a mixed group of participants. The main goals include checking kidney recovery, survival and daily function, bowel cleansing quality, mucus clearance, and long-term brain outcomes. Some trials are authorized, one is completed, and one is suspended. The studies use different comparison groups, such as normal saline or another bowel preparation product, to see whether Mannitol performs better or is non-inferior. Overall, the trial data show Mannitol being tested in both surgical and non-surgical settings with outcomes that matter to patient recovery.
Trial overview
The trial data show Mannitol being studied in several different clinical settings, not just one disease area. Most of the listed studies are Phase 3 trials, which means they are testing the treatment in larger groups and comparing it with another option or standard care. One study is Phase 2 and looks at a smaller, mixed group of participants with different conditions.
Across the studies, the target groups include kidney transplant donors and recipients, patients with traumatic brain injury, adults scheduled for elective colonoscopy, patients with bronchiectasia, and newborns with hypoxic-ischemic brain injury. The studies are designed to measure whether Mannitol helps with a specific clinical goal and whether results are better than a comparison treatment or usual care.
Kidney transplantation and delayed graft function
The MAVERICK study is a Phase 3 trial in people with end-stage renal disease and kidney transplantation. It compares Mannitol with normal saline in brain death donors and recipients of kidney allograft, which means a transplanted kidney. The main purpose is to see whether Mannitol can improve kidney transplant results by reducing delayed graft function, meaning the new kidney takes longer to start working well.
This study plans to enroll 466 participants and is currently authorised. Its primary outcome is days to kidney function, so the study is focused on how quickly the transplant begins to work after surgery.
Brain injury studies
One Phase 3 trial studies Mannitol in patients with traumatic brain injury. This study compares early continuous infusion of hypertonic saline solution with a group that includes Mannitol as one of the interventions listed in the trial data. The study includes 760 participants and is authorised.
The main outcomes are survival at 3 months and moderate to no dependency in daily activities at 6 months. In simple terms, the trial wants to know whether treatment helps people stay alive and keep enough independence to manage everyday life after the injury.
Another Phase 3 study includes newborns with hypoxic-ischemic encephalopathy, a type of brain injury caused by too little oxygen and blood flow around birth. Mannitol is listed as one of the interventions in this trial, which enrolls 503 participants and is authorised. The primary outcome compares death, severe neurodevelopmental impairment, and survival without severe impairment at 2 years of age.
Colonoscopy bowel preparation
The CLEARWAY trial is a Phase 3 study in people scheduled for elective colonoscopy. It compares Mannitol with Plenvu® for bowel preparation, which is the cleaning of the bowel before the test so the doctor can see clearly inside the colon. The study is completed and enrolled 520 participants.
The main outcome is the proportion of patients with adequate bowel cleansing, measured by the BBPS score, which is a standard scale for how clean the bowel is before colonoscopy. The trial is designed to show that Mannitol is not worse than the standard product for this purpose, which is called a non-inferiority study.
Bronchiectasia and mucus clearance
One Phase 3 trial studies Mannitol in patients with bronchiectasia. This study looks at inhaled treatment before ELTGOL physiotherapy, which is a breathing technique used to help clear mucus from the lungs. The trial includes 57 participants and is authorised.
The primary outcome is the change in sputum weight during the study. Sputum means mucus that is coughed up from the lungs, so the trial is checking whether the treatment helps people clear more mucus.
Newborn brain injury study
The newborn study is a Phase 3 trial in infants with early signs of hypoxic-ischemic encephalopathy after asphyxia. The trial is part of a broader treatment strategy that includes standard care and, when needed, therapeutic hypothermia, which means controlled cooling used to protect the brain. Mannitol is listed in the intervention data for this study.
The main endpoint is long-term outcome at 24 months, focusing on death versus severe neurodevelopmental impairment versus survival without severe impairment. This makes the study important for understanding whether treatment changes long-term development, not just short-term recovery.
What the trials measure
The trials use different endpoints because they study different medical problems. In kidney transplantation, the key measure is how quickly the kidney starts to work. In traumatic brain injury and newborn brain injury, the studies focus on survival and long-term function.
In colonoscopy preparation, the main measure is bowel cleanliness, while in bronchiectasia the focus is mucus clearance. The Phase 2 study in disorders of consciousness, vision impairment, and neurotypical volunteers is different because it explores several response types and measures alertness, cognition, neural complexity, and patient-reported experiences.
That Phase 2 study also shows how one trial can include very different participant groups when the research question is about how people respond to a treatment in general and in special patient groups. Its primary outcomes vary by group and include the Coma Recovery Scale-Revised for consciousness, sleepiness scales, neuropsychological tests, and ophthalmologic testing for vision.