RecruitingOBSERVATIONAL

Trifecta-Kidney cfDNA-MMDx Study

This study aims to find better ways to spot kidney rejection in people who have had a kidney transplant. Currently, tests often miss rejection or give false alarms. Researchers are comparing a new blood test called DD-cfDNA, which measures tiny bits of donor kidney DNA in the blood, with a very advanced biopsy test called MMDx. The MMDx system gives a detailed look at what's happening inside the kidney at a genetic level. By comparing these tests, scientists hope to learn if the blood test can reliably tell them when rejection is happening, without needing to do as many biopsies, or if it can improve how kidney biopsies are understood. This could lead to earlier and more accurate detection of rejection, helping patients keep their transplanted kidneys healthier for longer.

At a glance

Status

Recruiting

Sponsor

University of Alberta

Enrolment target

300

Start

01 Dec 2019

Estimated completion

01 Dec 2029

Kidney Transplant Rejection

What is this study about?

If you've had a kidney transplant, a big worry is your body rejecting the new kidney. Currently, doctors use several tests to look for rejection, like checking your blood and urine, or taking a small sample of the kidney for examination under a microscope (a biopsy). However, these tests aren't always perfect. Sometimes they miss rejection when it's happening, or they suggest rejection when it's not. This can lead to delays in treatment or unnecessary worry.

This study is trying to make these checks much better. It's focusing on two newer, more advanced tests. One is a blood test that looks for what's called 'donor-derived cell-free DNA' (DD-cfDNA). This is tiny snippets of DNA from your new kidney that float around in your blood. When the kidney is under stress, like during rejection, it releases more of this DNA. The other advanced test is a special way of looking at kidney biopsies called the Molecular Microscope® Diagnostic System (MMDx). This system looks very closely at the genes in your kidney tissue to give a much clearer picture of whether rejection is happening and what type it is.

By comparing the results of the DD-cfDNA blood test with the MMDx biopsy results, scientists hope to understand if the blood test can be a reliable and easier way to spot rejection. The goal is to find tools that can more accurately and earlier detect when a transplanted kidney is having problems, ultimately helping doctors give you the best possible care to protect your kidney.

Key takeaways

Aims to improve detection of kidney transplant rejection.
Compares new blood test (DD-cfDNA) with advanced biopsy analysis (MMDx).
Uses samples from tests you're already having.
Could lead to better care for transplant patients.
Does not involve extra medical procedures or treatments.
All adults with a kidney transplant who need a biopsy may be eligible.

Who may be eligible?

To be part of this study, you need to be an adult who has received a kidney transplant. The main requirement is that you are already scheduled to have a kidney biopsy because your doctor thinks it's needed for your care. This biopsy is sometimes called an 'indication biopsy' because it's being done to find out why your kidney might not be working as well as it should.

You won't be able to join the study if you choose not to take part, or if you are unable to understand and agree to participate. Also, if you have received more than one organ transplant (for example, a kidney and a liver), you won't be eligible for this particular study. The study includes all adults, regardless of their age or sex, as long as they meet the other criteria.

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.

Have I had a kidney transplant?
Am I scheduled to have a kidney biopsy for medical reasons?
Am I able to understand and give my permission to join the study?
Have I only received a kidney transplant (not multiple organs)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would mainly involve providing a blood sample at the same time you are having your planned kidney biopsy. The tissue sample from your biopsy would also be analysed using the special MMDx system. You would continue to receive your usual medical care and follow-up as determined by your doctors. There are no additional visits solely for this study beyond what you would normally have. The study simply involves collecting and analysing information from tests you are already having. The total duration of your participation would involve the collection of these samples and the analysis of the results, which happens in the background without requiring extra time from you.

Potential risks and benefits

Participating in this study involves very little extra risk, as it uses samples from tests (blood work and biopsy) you would already be undergoing as part of your standard medical care. There are no additional procedures or medications involved. The potential benefit is that the information gathered from this study could lead to better ways of detecting kidney rejection for future transplant patients, helping them keep their transplanted kidneys healthy for longer. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (31)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Tampa General Hospital
Verified postcode
Tampa, United States· Recruiting
University of Maryland School of Medicine
Verified postcode
Baltimore, United States· Recruiting
The Johns Hopkins University, School of Medicine
Verified postcode
Baltimore, United States· Recruiting
Detroit Medical Center, Harper University Hospital of Wayne State University
Verified postcode
Detroit, United States· Not yet recruiting
Henry Ford Hospital
Verified postcode
Detroit, United States· Recruiting
Barnes-Jewish Hospital, Washington University at St. Louis
Verified postcode
St Louis, United States· Recruiting
University Hospitals Cleveland Medical Ctr.
Verified postcode
Cleveland, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
Intermountain Transplant Services
Verified postcode
Murray, United States· Recruiting
Virginia Commonwealth University Medical Center
Verified postcode
Richmond, United States· Recruiting
Division of Nephrology & UW Organ Transplant Center University of Washington
Verified postcode
Seattle, United States· Recruiting
Department of Nephrology, The Royal Melbourne Hospital 1 South East
Verified postcode
Melbourne, Australia· Recruiting

Common questions

What is DD-cfDNA?

It's a blood test that looks for tiny pieces of DNA from your transplanted kidney that are found in your bloodstream. Higher levels can suggest the kidney is under stress or being rejected.

What is MMDx?

It's a very advanced way of analysing a kidney biopsy. Instead of just looking at cells, it checks the genetic activity within the kidney tissue to get a detailed picture of what's happening.

Do I need extra tests for this study?

No, the study will use samples from blood and biopsy tests you are already scheduled to have as part of your routine medical care.

Will this study change my treatment?

No, this study is for research and won't directly change your current treatment. Your doctors will continue to manage your care based on standard practices.

Why is this study important?

It aims to find more accurate ways to detect kidney rejection earlier, which could help transplant patients receive better and more timely treatment in the future.

How to find out more

Konrad S Famulski, PhD

konrad@ualberta.ca 1 780 492 1725 Official trial record

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