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Study on the Impact of Acetylcysteine and Drug Combination on Kidney Function in Living Donor Kidney Transplant Patients

Verified siteRegistered drugNo 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 focuses on the process of renal transplantation involving a living donor. The study aims to understand how the kidney function of both the donor and the recipient changes after the transplant. The treatment being studied is a special solution called Nephrotect, which is a mixture of various amino acids. Amino acids are the building blocks of proteins and are essential for many body functions. This solution is given through a method called intravascular use, which means it is administered directly into the bloodstream.

The purpose of the study is to evaluate how the kidney function of the donor and recipient evolves after the transplant. The study will look at the kidney function before and after the transplant to see how it changes. The kidney's ability to handle extra work, known as renal reserve, will also be assessed. This is done by giving an infusion of the amino acid solution to see how the kidneys respond.

Participants in the study will be monitored over time to observe changes in their kidney function. The study will help to better understand the impact of the donor's kidney function and reserve on the outcomes of the transplant. This information could be valuable for improving the success of kidney transplants from living donors in the future.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, ensure that all eligibility criteria are met. This includes being over 18 years old, being referred to the nephrology service for inclusion in the living donor renal transplant program, and having no contraindications for donation or transplant.

    Sign the informed consent form, confirming understanding and agreement to participate in the study.

  2. Step 2

    Pre-transplant assessment

    Undergo a pre-transplant assessment to evaluate renal function and renal reserve. This involves measuring renal function using a reference standard called plasma clearance of iohexol.

    Renal reserve will be assessed by an intravenous infusion of an amino acid solution called Nephrotect, which contains various amino acids such as acetylcysteine, glycine, and l-lysine acetate.

  3. Step 3

    Transplant procedure

    Participate in the renal transplantation procedure as either a donor or recipient, as part of the living donor renal transplant program.

  4. Step 4

    Post-transplant monitoring

    After the transplant, renal function will be monitored to evaluate its evolution. This involves regular assessments using the same reference standard, plasma clearance of iohexol.

    The study aims to observe the impact of pre-donation renal reserve on post-transplant renal function in both donors and recipients.

Who can join the trial?

4 criteria

  • Must be over 18 years old.
  • Must be a donor or recipient referred to the Nephrology Service for the living donor kidney transplant program, with no detected reasons that would prevent donation or transplant.
  • Must be in clinical stability, meaning no recent health issues like infections, sudden kidney problems, or heart disease in the last month.
  • Must sign an informed consent, which is a document that explains the study and confirms your agreement to participate.

Who cannot join the trial?

4 criteria

  • Patients who have had a renal transplantation (kidney transplant) from a living donor cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give informed consent, cannot participate.
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Investigated drugs

The clinical trial you are interested in does not provide specific information about the medications or therapies involved. The data available focuses on the evaluation of kidney function in living donor transplant donors and recipients. If you have more specific information or another source that lists the medications or therapies, please provide it, and I will be happy to help describe them.

What is already known about the treatment

The provided data does not specify any medication names or details about specific medications involved in the clinical trial. Therefore, I am unable to create descriptions for medications without additional information. If you have specific medication names or details, please provide them for further assistance.

Investigated diseases

Renal Transplantation – Renal transplantation involves the surgical procedure of transferring a healthy kidney from a living or deceased donor to a recipient whose kidneys are no longer functioning properly. The disease progression in this context refers to the changes in kidney function after the transplant. Initially, the transplanted kidney may experience a period of adjustment as it begins to function in the recipient's body. Over time, the recipient's body may accept or reject the new kidney, which can affect how well the kidney works. The donor's remaining kidney also undergoes changes as it compensates for the loss of the donated kidney. Monitoring the evolution of renal function in both the donor and recipient is crucial to understanding the long-term outcomes of the transplantation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519757-11-00Protocol codeRR-DVIVOEstimated enrolment60 patientsSponsorUniversity Hospital Of Canary Islands

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