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Study on Alkaline Phosphatase for Reducing Kidney Transplant Complications in Patients with End-Stage Kidney Disease

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as ischemia reperfusion injury, which can occur during kidney transplantation. This condition can lead to a complication called delayed graft function, where the transplanted kidney does not work immediately and the patient may need dialysis within the first week after the transplant. The trial is investigating whether a treatment using a substance called alkaline phosphatase, bovine, marketed under the name bRESCAP, can help prevent this injury and reduce the duration of delayed graft function.

Participants in the study will receive either the treatment with bRESCAP or a placebo, which is a substance with no active medication. The treatment is given as an IV infusion, which means it is administered directly into a vein. The study aims to see if the treatment can decrease the need for dialysis and improve kidney function after transplantation. The trial will also monitor other factors such as the length of hospital stay, kidney function over time, and any potential rejection of the transplanted kidney.

The study will follow participants for up to a year to gather comprehensive data on the effectiveness of the treatment. This includes measuring kidney function through tests like creatinine clearance and estimated glomerular filtration rate (eGFR), as well as checking for any signs of kidney rejection or other complications. The ultimate goal is to improve outcomes for patients receiving kidney transplants from donors who have experienced circulatory death.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Eligibility is confirmed for individuals over 18 years old who are recipients of a donor kidney from a donor who has experienced cardiac death. Written consent is required.
Step 2
Treatment administration
The treatment involves the administration of alkaline phosphatase through an intravenous infusion. This is a solution for injection.
A placebo, which is a 0.9% sodium chloride solution, may be administered instead of the active treatment. This is also given through an intravenous infusion.
Step 3
Monitoring and follow-up
The primary goal is to observe the difference in the duration of delayed graft function (DGF) between the treatment and placebo groups. DGF is defined as the need for dialysis within 7 days after transplantation.
Secondary observations include the duration of hospitalization, incidence of persistent dialysis DGF, kidney function tests, and overall health outcomes at various intervals up to one year after transplantation.
Step 4
End of study
The study is expected to conclude by December 1, 2026. Final assessments will include kidney function and overall health status.

Who can join the trial?

3 criteria

Patients who are receiving a kidney from a donor who has passed away due to cardiac death while in intensive care. This is known as a donor cardiac death type III according to the 'Maastricht classification'.
Must be older than 18 years.
Must be able to provide written informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

Patients who are not kidney transplantation donors receiving kidneys from donation after circulatory death (DCD).
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might have special needs or circumstances that require extra protection.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

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Investigated drugs

Alkaline Phosphatase is being studied to see if it can help prevent damage to kidney tissue that can occur when blood supply returns to the tissue after a period of lack of oxygen, known as ischemia reperfusion injury. This medication is being tested in the context of kidney transplants from deceased donors. The goal is to see if it can reduce the time the new kidney takes to start working properly, which is sometimes delayed, requiring dialysis within the first week after the transplant.

Alkaline Phosphatase, Bovine

What is already known about the treatment

Alkaline Phosphatase – This medication is administered intravenously and is currently being studied in clinical trials for its potential to prevent ischemia reperfusion injury in kidney transplantation. It is not yet widely used in standard medical practice, as research is ongoing to determine its effectiveness and safety. The main therapeutic indication is to reduce delayed graft function in patients receiving kidneys from donors after circulatory death. At the molecular level, alkaline phosphatase works by dephosphorylating molecules, which may help reduce inflammation and tissue damage during the transplantation process. It is classified pharmacologically as an enzyme.

Investigated diseases

End Stage Kidney Disease – This is a condition where the kidneys have lost nearly all their ability to function effectively, leading to the accumulation of waste products and fluid in the body. It often requires dialysis or a kidney transplant to maintain life. The disease progresses as the kidneys gradually lose their filtering ability, which can result in symptoms like fatigue, swelling, and difficulty concentrating. Over time, the kidneys' inability to filter blood properly can lead to complications such as high blood pressure, anemia, and bone disease. In the context of kidney transplantation, the focus is on managing the transition to a new kidney, which may involve challenges like delayed graft function.