Evaluation of Mannitol Versus Normal Saline on Delayed Graft Function in Kidney Transplant Recipients from Brain Death Donors: A Double-Blind, Placebo-Controlled RCT

The primary objective of this study is to determine if **mannitol** can be utilized to enhance the outcomes of kidney transplantation by reducing delayed graft function. This is clinically significant as delayed graft function is a common complication following kidney transplantation, which can adversely affect graft survival and patient outcomes. By potentially mitigating this complication, mannitol could improve the overall success rate of kidney transplants.

Secondary objectives include:

• To assess whether the use of mannitol decreases early kidney graft rejections.
• To evaluate if the use of mannitol improves kidney graft survival.

The clinical trial focuses on individuals with **end-stage renal disease** undergoing **kidney transplantation**. The study population includes both male and female participants, with an age range of 18 to 64 years. Participants are generally in a stable health condition, aside from their primary medical condition. The trial does not involve a vulnerable population. The selection criteria include patients receiving a kidney allograft from an adult brain-dead donor. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **mannitol** in improving outcomes in kidney transplantation by reducing delayed graft function. This study is a randomized, double-blind, placebo-controlled trial involving patients receiving a kidney allograft from adult brain-dead donors. The trial will compare the effects of mannitol, administered as an intravenous solution for infusion, against a placebo of normal saline. The primary endpoint is the number of days to kidney function, while secondary endpoints include delayed kidney graft function, biopsy-proven acute kidney graft rejection within three months, and estimated glomerular filtration rate (eGFR) at 7 days, 1 month, and 3 months.

The trial is expected to commence recruitment on March 3, 2025, and is estimated to conclude by December 31, 2048. Participants will be involved in the study for a maximum treatment period of one day, with a maximum daily dose of 200 ml of the investigational product. The study will include several key visits: an initial screening visit to assess eligibility based on inclusion criteria, followed by the administration of the investigational product. Follow-up visits will be scheduled to monitor the primary and secondary endpoints, with the final visit marking the end of the study for each participant.

Participants may be withdrawn from the study if they experience adverse reactions, fail to comply with the study protocol, or if the investigator deems it necessary for their safety. The trial is categorized as a low-intervention study, utilizing approved medication, and is conducted under strict regulatory guidelines to ensure the safety and well-being of all participants. The study aims to provide valuable insights into the potential benefits of mannitol in the context of kidney transplantation, contributing to improved clinical practices and patient outcomes.

The clinical trial involves the administration of **Mannitol**, a chemical substance used as the experimental medication. Mannitol is provided in the form of a **solution for infusion** and is administered **intravenously**. The maximum daily dose of Mannitol is 200 ml, with a total maximum dose of 200 ml over the treatment period. The treatment period is limited to one day. Mannitol is utilized in this study to evaluate its efficacy in improving kidney transplantation outcomes by reducing delayed graft function. Participant compliance with the dosing schedule is monitored to ensure adherence to the protocol.

The study also includes a non-experimental treatment, which serves as a comparator. This comparator is categorized under the ATC code **V07AB**, which includes solvents and diluting agents, such as irrigating solutions. The comparator is also administered in the form of a fluid solution for infusion, delivered **intravenously**. The dosing regimen for the comparator mirrors that of Mannitol, with a maximum daily and total dose of 200 ml over a one-day treatment period. The use of this comparator allows for a double-blinded, placebo-controlled design, ensuring the reliability of the trial results.

The efficacy of the clinical trial titled "Mannitol versus normal saline in brain death donors and recipients of kidney allograft on delayed graft function (MAVERICK)" will be assessed using both primary and secondary endpoints. The primary endpoint is the number of days to kidney function recovery, as detailed in the trial protocol. Secondary endpoints include the incidence of **Delayed Graft Function (DGF)**, biopsy-proven acute kidney graft rejection within three months, and the estimated glomerular filtration rate (eGFR) measured at 7 days, 1 month, and 3 months post-transplantation.

Data collection will involve the use of laboratory tests and clinical assessments to monitor these parameters at specified timepoints. The trial is designed as a double-blinded, placebo-controlled randomized clinical trial, ensuring that the assessment of efficacy is conducted with methodological rigor. The trial aims to determine if mannitol can improve kidney transplantation outcomes by reducing delayed graft function, thereby providing valuable insights into the management of kidney allograft recipients.