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Alkaline Phosphatase, Bovine

Researchers are exploring the potential of Alkaline Phosphatase, Bovine (bRESCAP) in reducing complications associated with kidney transplants. This Phase 2 clinical trial aims to investigate whether this drug can prevent ischemia reperfusion injury and decrease the duration of delayed graft function (DGF) in patients receiving kidneys from donors after circulatory death. The study focuses on improving outcomes for individuals with end-stage kidney disease undergoing transplantation.

Table of Contents

What is Alkaline Phosphatase (bRESCAP)?

Alkaline Phosphatase, also known by its product name bRESCAP, is a protein-based medication being studied for use in kidney transplant patients[1]. It’s important to note that this is a bovine (cow-derived) form of alkaline phosphatase, which means it comes from cows rather than being produced in a lab or derived from human sources[1].

Medical Conditions Treated

bRESCAP is being investigated for use in patients with end-stage kidney disease who are receiving kidney transplants from donors after circulatory death (DCD)[1]. End-stage kidney disease is a condition where a person’s kidneys have stopped working well enough for them to survive without dialysis or a kidney transplant.

How It Works

The main goal of using bRESCAP is to prevent a complication called ischemia-reperfusion injury in deceased donor kidney transplantation[1]. This type of injury can occur when blood supply returns to the kidney after a period without oxygen, which can happen during the transplant process. By preventing this injury, researchers hope to reduce the duration of delayed graft function (DGF), a situation where the transplanted kidney doesn’t work immediately and the patient needs dialysis within the first week after transplant[1].

Potential Benefits

Researchers are studying whether bRESCAP can provide several benefits for kidney transplant patients, including:

  • Shorter hospital stays after kidney transplantation[1]
  • Decreased need for long-term dialysis after transplant[1]
  • Improved kidney function in the first week after transplantation[1]
  • Better kidney perfusion (blood flow through the kidney) six days after transplant[1]
  • Improved kidney function at 3 months and 1 year after transplantation[1]
  • Reduced risk of transplant rejection within the first year[1]
  • Improved survival rates at 28 days, 90 days, and 1 year after transplant[1]

Who Can Receive This Treatment?

As this treatment is still being researched, it’s only available to certain patients participating in clinical trials. Currently, eligible patients are:

  • Recipients of kidneys from donors after circulatory death (a specific type of deceased donor)[1]
  • Able to provide written informed consent[1]

However, some people cannot participate in the study, including:

  • Strict vegetarians (as the medication is derived from cows)[1]
  • People with a history of allergy to bovine (cow) proteins[1]

How is it Administered?

bRESCAP is given as a solution for injection through intravenous (IV) infusion. This means it’s delivered directly into the bloodstream through a vein[1]. The maximum daily dose being studied is 50,000 international units (IU), with a maximum total dose of 75,000 IU over a treatment period of up to 3 days[1].

Ongoing Research

bRESCAP is currently being studied in a Phase 2 clinical trial[1]. This means that while it has shown promise in earlier studies, it’s still being tested to determine its effectiveness and safety in larger groups of patients. The results of this study will help researchers understand how well bRESCAP works and whether it should move on to larger, more definitive trials.

It’s important to remember that while the potential benefits of bRESCAP are exciting, it’s still an experimental treatment. Patients should always discuss their treatment options with their healthcare providers and consider all available information before making decisions about their care.

Aspect Details
Drug Name Alkaline Phosphatase, Bovine (bRESCAP)
Trial Phase Phase 2
Main Objective Prevent ischemia reperfusion injury and decrease delayed graft function duration
Target Population End-stage kidney disease patients receiving transplants from donors after circulatory death
Primary Endpoint Difference in delayed graft function duration between treatment and placebo groups
Key Secondary Objectives Reduce hospitalization duration, improve kidney function markers, assess mortality rates
Administration Intravenous infusion
Maximum Daily Dose 50,000 IU
Maximum Total Dose 75,000 IU
Treatment Duration Up to 3 days

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to study whether Alkaline Phosphatase, Bovine can prevent ischemia reperfusion injury in deceased donor kidney transplantation and decrease the duration of delayed graft function (DGF).
  • Who can participate in this trial? Patients receiving kidneys from donors after circulatory death (type III according to the Maastricht classification) can participate. They must be able to give written informed consent.
  • Are there any specific exclusion criteria? Yes, strict vegetarians and individuals with a history of allergy to bovine proteins are excluded from the trial.
  • How is the drug administered? The drug, bRESCAP, is administered as a solution for injection through IV infusion.
  • What are some of the secondary objectives of the trial? Secondary objectives include decreasing hospitalization duration, reducing the incidence of persistent dialysis DGF, improving kidney function markers, and assessing mortality rates at various time points after transplantation.

Ongoing Clinical Trials on Alkaline Phosphatase, Bovine

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

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Alkaline Phosphatase to Prevent Inflammation and Kidney Injury in Patients Undergoing Open-Heart Surgery

    Not yet recruiting

    3 1
    Investigated drugs:
    Austria Belgium

Glossary

  • Alkaline Phosphatase: An enzyme found in various body tissues that helps remove phosphate groups from molecules. In this trial, a bovine (cow) version is being tested as a potential treatment.
  • Ischemia Reperfusion Injury: Damage that occurs when blood supply returns to tissue after a period of lack of oxygen. In kidney transplants, this can happen when blood flow is restored to the organ.
  • Delayed Graft Function (DGF): A complication in kidney transplants where the new kidney doesn't function immediately, requiring dialysis within the first week after transplantation.
  • Glomerular Filtration Rate (GFR): A measure of how well the kidneys are filtering waste from the blood. It's an important indicator of kidney function.
  • Proteinuria: The presence of excess proteins in the urine, which can be a sign of kidney damage or disease.
  • Biopsy-proven rejection: When a small sample of the transplanted kidney shows signs that the body's immune system is attacking the new organ.
  • Primary non-function: A serious complication where the transplanted kidney never starts working properly, defined in this study as dialysis dependency or very low kidney function at 3 months post-transplant.

References

  1. http://clinicaltrials.eu/trial/study-on-alkaline-phosphatase-for-reducing-kidney-transplant-complications-in-patients-with-end-stage-kidney-disease/