Clinical Research Directory

Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation

The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.

ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function. The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational follow-up period. During part A, after the screening period, eligible participants will be randomized to receive either ARGX-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). After the treatment period, participants will enter a follow-up period of up to 12 weeks. The total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part B of the study.

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation

The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients

This is an exploratory, multicenter, single-arm study designed to evaluate the efficacy of perioperative Vonoprazan Fumarate in reducing the incidence of Delayed Graft Function (DGF) in deceased-donor kidney transplant recipients. DGF is a common early complication that significantly impacts graft function and long-term transplant survival. This study aims to explore how Vonoprazan Fumarate, a potassium-competitive acid blocker (P-CAB), can potentially improve macrophage phagocytic function, reduce kidney inflammation, and enhance early kidney function recovery. Patients aged 18 years and older who are undergoing first-time deceased-donor kidney transplantation will be enrolled. Vonoprazan Fumarate will be administered daily starting on the day of transplantation and continuing for seven days post-surgery. The primary endpoint is DGF incidence, while secondary endpoints include kidney function recovery, serum creatinine reduction, estimated glomerular filtration rate, and safety assessments. Adverse events will be monitored, and the study will also explore potential biomarkers for inflammation and graft function. The study is expected to provide insights into a potential new therapeutic strategy to reduce DGF and improve early kidney transplant outcomes, potentially benefiting future kidney transplant patients by offering a safer and more effective perioperative treatment option.

Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.

Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys

The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.

Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations

Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.

Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation

Furosemide is an old drug that has been used frequently in the postoperative period of kidney transplantation, aiming to achieve adequate urine output. There is no previous study that directly evaluate the urine response to standardized dose of furosemide in the postoperative period. The objective is to measure the urine output after standardized dose of furosemide is delivered, as a biomarker to predict the graft function in perioperative period.

Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation

The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.