Prospera + MMDx for Kidney Transplant Rejection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the relationship between certain blood markers, such as DD-cfDNA levels and HLA antibodies (a type of immune system protein), and kidney health in transplant patients. Researchers use a tool called the Molecular Microscope® (MMDx) to analyze kidney biopsy samples. The trial seeks individuals who have received a kidney transplant and require a biopsy as part of their regular care. Participants should be comfortable with the standard biopsy process as part of their treatment routine. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance kidney transplant outcomes.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that HLA antibodies, part of the immune system, can have mixed effects. Some studies indicate that certain HLA antibodies may be linked to issues like transplant rejection and lower survival rates of transplanted kidneys, especially when these antibodies interact with a part of the immune system called complement. However, HLA antibodies do not always cause problems, so monitoring them in transplant patients is crucial.
The MMDx system, which examines transplant biopsies at a molecular level, is generally considered safe. It helps doctors understand the condition of the transplanted organ by measuring gene activity. Some studies have found that MMDx results do not always align with traditional biopsy readings, potentially influencing treatment decisions. However, no major safety concerns have been associated with its use.
Prospera is a blood test that checks for donor-derived cell-free DNA, aiding in the early detection of kidney transplant rejection. This non-invasive test requires only a blood sample and is generally regarded as safe and useful for identifying potential problems before they become serious.
Overall, while some risks are associated with HLA antibodies, both MMDx and Prospera are safe tools for monitoring kidney transplant health.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to refine how we assess kidney transplant health through innovative techniques. Traditional methods rely heavily on biopsies and antibody tests, but this trial explores the use of molecular microscope diagnostics (MMDx) and cell-free DNA (cfDNA) testing like Prospera. These methods offer a more detailed, non-invasive look at the transplant's condition. By potentially detecting issues before they become significant, these techniques could lead to faster, more accurate interventions, improving outcomes for transplant patients significantly.
What evidence suggests that this trial's treatments could be effective for kidney transplant biopsies?
This trial will evaluate the effectiveness of different diagnostic tools for kidney transplant patients undergoing biopsies for clinical indications. Research has shown that certain HLA antibodies can help predict the success of a kidney transplant. One study found that patients with these antibodies had a 95.6% chance of their transplant functioning well after one year. Another study found that early detection of these antibodies can lead to better kidney health.
The Molecular Microscope Diagnostic System (MMDx), which may be used to evaluate participants in this trial, provides detailed information about kidney health. It can detect signs of rejection or damage, aiding doctors in managing treatment more effectively. Research suggests that using MMDx could reduce the risk of losing the transplanted kidney by at least 5%.
The Prospera test, another diagnostic tool under study in this trial, examines donor DNA in the blood. Studies have shown it can detect early signs of transplant rejection, allowing doctors to initiate treatment sooner. In one study, patients with favorable Prospera results experienced much better outcomes after one year.16789Who Is on the Research Team?
Philip F Halloran, MD, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo kidney transplant biopsies and blood tests for DD-cfDNA and MMDx calibration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HLA antibody
- MMDx
- Prospera
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Natera, Inc.
Industry Sponsor
One Lambda
Collaborator
Citations
Preexisting Donor-Specific HLA Antibodies Predict ...
One- and 8-year graft survivals were 95.6 and 74.5% in patients with peak HLA-DSA+/rCXM− and, respectively, 76.4 and 29.1% in patients with peak HLA-DSA+/rCXM+.
2.
frontierspartnerships.org
frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2025.14424/fullEarly Donor-Specific HLA Antibodies Detected by Screening ...
The aim of our study is to evaluate the impact of early HLA antibody screening in the first month posttransplant on kidney graft outcomes and ...
Five-Year Outcomes in Living Donor Kidney Transplants ...
Our results showing a 5-year patient survival of 83.5% % were similar to those of HLA-incompatible kidney transplant recipients recently reported by the Johns ...
Kidney transplant outcomes in HLA desensitized patients ...
Graft survival probability at 1-year was 95% [95%IC 93 – 98] and 97 [95%IC 93 – 100] in the HLAc and CDC-positive HLAi group (p=ns). Median ...
Influence of CDC‑XM and HLA compatibility on clinical ...
The present study showed that CDC‐negativity and improved HLA matching help to promote the recovery of renal function in kidney transplant recipients.
De Novo Anti-HLA Antibody After Pandemic H1N1 and ...
Multiple doses of influenza vaccine may lead to the production of anti-HLA antibodies in a significant proportion of kidney transplant recipients.
Utility of Routine Post Kidney Transplant Anti-HLA Antibody ...
In 95% of patients with dnDSA, an immunizing event was identified in their medical records. dnDSA was detected in 46 of 4267 systematic ...
Impact of Low-Level Donor-Specific Anti-HLA Antibody on ...
Class I HLA-DSA is associated with acute ABMR and early graft loss, whereas class II HLA-DSA is associated with chronic ABMR and transplant glomerulopathy [33].
Complement-Binding Anti-HLA Antibodies and Kidney- ...
Patients with complement-binding donor-specific anti-HLA antibodies after transplantation had the lowest 5-year rate of graft survival (54%).
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