Table of Contents

• Trial overview
• Kidney transplantation and delayed graft function
• Brain injury studies
• Colonoscopy bowel preparation
• Bronchiectasia and mucus clearance
• Newborn brain injury study
• What the trials measure

Trial overview

The trial data show Mannitol being studied in several different clinical settings, not just one disease area.^[1] 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.^[1] One study is Phase 2 and looks at a smaller, mixed group of participants with different conditions.^[2]

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.^{[1][2] 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.[1]}

Kidney transplantation and delayed graft function

The MAVERICK study is a Phase 3 trial in people with end-stage renal disease and kidney transplantation.^[1] It compares Mannitol with normal saline in brain death donors and recipients of kidney allograft, which means a transplanted kidney.^[1] 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.^[1]

This study plans to enroll 466 participants and is currently authorised.^[1] Its primary outcome is days to kidney function, so the study is focused on how quickly the transplant begins to work after surgery.^[1]

Brain injury studies

One Phase 3 trial studies Mannitol in patients with traumatic brain injury.^[1] 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.^[1] The study includes 760 participants and is authorised.^[1]

The main outcomes are survival at 3 months and moderate to no dependency in daily activities at 6 months.^[1] 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.^[1]

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.^[3] Mannitol is listed as one of the interventions in this trial, which enrolls 503 participants and is authorised.^[3] The primary outcome compares death, severe neurodevelopmental impairment, and survival without severe impairment at 2 years of age.^[3]

Colonoscopy bowel preparation

The CLEARWAY trial is a Phase 3 study in people scheduled for elective colonoscopy.^[4] 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.^[4] The study is completed and enrolled 520 participants.^[4]

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.^[4] 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.^[4]

Bronchiectasia and mucus clearance

One Phase 3 trial studies Mannitol in patients with bronchiectasia.^[5] This study looks at inhaled treatment before ELTGOL physiotherapy, which is a breathing technique used to help clear mucus from the lungs.^[5] The trial includes 57 participants and is authorised.^[5]

The primary outcome is the change in sputum weight during the study.^[5] Sputum means mucus that is coughed up from the lungs, so the trial is checking whether the treatment helps people clear more mucus.^[5]

Newborn brain injury study

The newborn study is a Phase 3 trial in infants with early signs of hypoxic-ischemic encephalopathy after asphyxia.^[3] 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.^[3] Mannitol is listed in the intervention data for this study.^[3]

The main endpoint is long-term outcome at 24 months, focusing on death versus severe neurodevelopmental impairment versus survival without severe impairment.^[3] This makes the study important for understanding whether treatment changes long-term development, not just short-term recovery.^[3]

What the trials measure

The trials use different endpoints because they study different medical problems.^{[1][3][4][5] In kidney transplantation, the key measure is how quickly the kidney starts to work.[1] In traumatic brain injury and newborn brain injury, the studies focus on survival and long-term function.[1][3]}

In colonoscopy preparation, the main measure is bowel cleanliness, while in bronchiectasia the focus is mucus clearance.^{[4][5] 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.[2]}

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.^[2] Its primary outcomes vary by group and include the Coma Recovery Scale-Revised for consciousness, sleepiness scales, neuropsychological tests, and ophthalmologic testing for vision.^[2]