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Allosure Testing for Lung Transplant Rejection
N/A
Waitlist Available
Led By Pablo Sanchez, MD
Research Sponsored by Pablo Sanchez
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post transplant
Awards & highlights
Study Summary
This trial looks at using a new method, Allosure, to identify and quantify cell-free DNA in order to better understand allograft injury and its relationship to allograft failure.
Who is the study for?
This trial is for adults over 18 who have recently received a lung transplant and can consent to participate. They must understand English to follow the study procedures. People with previous transplants, multi-organ transplants, or those unable to have blood drawn are excluded.Check my eligibility
What is being tested?
The trial is testing Allosure, a method of measuring donor-derived cell-free DNA in the bloodstream of new lung transplant recipients. The goal is to see if this can predict early signs of organ rejection and long-term success of the transplant.See study design
What are the potential side effects?
Since Allosure involves regular blood tests rather than medication or invasive procedures, side effects are minimal but may include discomfort at the blood draw site and bruising.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant
+29 moreSecondary outcome measures
Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant
Side effects data
From 2023 Phase 4 trial • 17 Patients • NCT0417709517%
Elevated Creatinine
8%
Knee Pain
8%
Fatigue
8%
Urinary Tract Infection
8%
Proteinuria
8%
Elevated LFTs
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept Treated Patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: Allosure ArmExperimental Treatment1 Intervention
All subjects will be in arm one and will have AlloSure blood draws at multiple time points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allosure
2020
Completed Phase 4
~20
Find a Location
Who is running the clinical trial?
Pablo SanchezLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
CareDxIndustry Sponsor
25 Previous Clinical Trials
15,431 Total Patients Enrolled
Pablo Sanchez, MDPrincipal Investigator - Associate Program Director Residency Program
Children's Hospital of Pittsburgh of UPMC, Eye & Ear Hospital of Pittsburgh, Magee-Women's Hospital of UPMC, Select Specialty Hospital of Pittsburgh-UPMC, UPMC Montefiore, UPMC Presbyterian, UPMC Shadyside
8 Previous Clinical Trials
83,639 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical trial?
"As per information listed on clinicaltrials.gov, this particular medical experiment has reached its recruitment goals and is not currently accepting any more participants. Initially posted on June 29th 2020 and last updated on June 1st 2022, there are however 5 other trials that still require volunteers at present."
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