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VIRTUUS Children's Study

The VIRTUUS Children's Study is trying to find better, less invasive ways to monitor kidney transplants in children. Currently, the best way to check for problems like rejection (when the body tries to fight off the new kidney) or infection is often a biopsy, which involves taking a small piece of the kidney. This can be difficult for children. This study hopes to discover early warning signs of these issues using simple tests, like urine samples. By catching problems sooner, doctors might be able to help children's new kidneys last longer, reducing the need for more transplants throughout their lives.

At a glance

Status
Active not recruiting
Sponsor
Children's Hospital of Philadelphia
Enrolment target
445
Start
10 Aug 2017
Estimated completion
31 Mar 2026

What is this study about?

When children receive a new kidney through a transplant, it's a huge step towards better health. However, keeping that new kidney healthy for many years can be a challenge. Sometimes, the body's immune system tries to reject the new kidney, or infections like the BK virus can cause problems. Currently, to find out if these things are happening, doctors often need to do a procedure called a biopsy, where they take a tiny sample of the kidney using a needle. This can be uncomfortable and upsetting for children, and sometimes they even need to stay in the hospital for it.

This is where the VIRTUUS Children's Study comes in. Its main goal is to find new, gentler ways to check on the health of a child's transplanted kidney. Instead of biopsies, the researchers are looking for natural signals or 'markers' in things like urine that could show early signs of trouble. Think of it like a smoke detector for your kidney – it would warn you there's a problem before a big fire starts.

By finding these early warning signs, doctors could react sooner if something is wrong. This could help prevent major damage to the kidney, potentially making the transplanted kidney last much longer. For children who receive kidney transplants, having their new kidney work well for as long as possible is incredibly important, as it means fewer operations and healthier lives.

Key takeaways

  • New study to find gentler ways to check children's kidney transplants.
  • Aims to detect rejection or infection early without needing biopsies.
  • Could help transplanted kidneys last longer for children.
  • Focuses on less invasive tests like urine samples.
  • Participation could improve future kidney care for many children.

Who may be eligible?

This study is looking for children and young people between 2 and 18 years old.

To be considered for the study, you must either be getting your first kidney transplant, or have had a kidney transplant before and are scheduled to have a kidney biopsy anyway as part of your regular care.

Before taking part, your parents or guardians would need to give their permission, and if you are old enough to understand, you would also need to agree to be in the study. Importantly, your main medical team would need to confirm that it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 2 and 18 years old?
  2. Are you getting a kidney transplant soon, or have you already had one?
  3. If you have a transplant, are you having a kidney biopsy as part of your normal care?
  4. Have your parents or guardians agreed, and if you're old enough, have you agreed too?
  5. Has your regular doctor said it's safe for you to take part?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves isn't fully described here. However, based on the study's goal, it's likely that if you join, you would be asked to provide samples like urine or blood at specific times. These samples would then be checked for special 'markers' that could show how your kidney transplant is doing. You would probably have regular follow-up appointments, but these would likely coincide with appointments you're already having for your kidney care. The total duration of participation is not specified, but the study focuses on long-term kidney health.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers find better ways to monitor children's transplanted kidneys. This could lead to earlier detection of problems and potentially help transplanted kidneys last longer for many children in the future. As the study aims to use less invasive methods, the direct risks from the study procedures themselves are expected to be very low, likely involving only giving urine or blood samples, which are generally safe. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (13)

  • University of California-San Diego, Rady Children's Hospital
    Verified postcode
    La Jolla, United States
  • Children's Hospital Los Angeles
    Verified postcode
    Los Angeles, United States
  • University of California
    Verified postcode
    Los Angeles, United States
  • Stanford University
    Verified postcode
    Palo Alto, United States
  • Children's National Medical Center
    Verified postcode
    Washington D.C., United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Verified postcode
    Chicago, United States
  • University of Minnesota
    Verified postcode
    Minneapolis, United States
  • Joan & Sanford I. Weill Medical College of Cornelle University
    Verified postcode
    New York, United States
  • Cincinnati Children's Hospital Medical Center
    Verified postcode
    Cincinnati, United States
  • CHOP
    Verified postcode
    Philadelphia, United States
  • University of Pennsylvania
    Verified postcode
    Philadelphia, United States
  • Seattle Children's Hospital
    Verified postcode
    Seattle, United States

Common questions

What is a 'biomarker' mentioned in the study?

A biomarker is a natural signal in the body, like something found in your urine, that can tell doctors about your health or if there's a problem.

Why is it important to find problems early?

Catching problems like rejection or infection early means doctors can start treatment sooner, which can help your new kidney stay healthy for longer.

Will I still get my usual medical care?

Yes, taking part in this study will not change the standard medical care you receive for your transplanted kidney.

Is this study only for children getting their first transplant?

No, it's for children getting their first transplant or those who have already had a transplant and are scheduled for a biopsy.

What happens to the information from my samples?

The samples will be used by researchers to find new ways to understand and monitor kidney transplant health in children, always keeping your information private.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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