Lung Transplant RejectionNCT05170425
LAMBDA 002 (Lung Registry) Study
An observational study of Lung Transplant Rejection, run by Natera, Inc. at 11 sites in United States.
Trial summary
The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- Prospera
- Type of treatment
- Medical device
- How many people
- 154 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Nov 2022to May 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung Transplantation Patient
Who may be able to join
- Age 18 or older at the time of enrollment.
- Underwent a first single or bilateral deceased-donor lung transplant. 3) Allograft was from a genetically different donor (e.g., not an identical twin).
- 4) Meets criteria for one of the two study cohorts:
- Cohort 1: i) Previously enrolled and randomized in LAMBDA 001 (TBBx surveillance or Prospera surveillance) AND ii) Enrolled at least 12 and up to 18 months post-transplant b) Cohort 2: i) Not previously randomized in LAMBDA 001 (may have been enrolled if randomization did not occur) AND ii) Enrolled less than or equal to 12 months post-transplant 5) Prospera testing is planned as part of routine post-transplant management.
Who cannot join
- Patients are not eligible for the study if they meet any of the following criteria:
- 1) Recipient of multi-organ transplant at the time of lung transplant. 2) Prior recipient of any solid organ or hematopoietic (bone marrow or stem cell) transplant.
- 3) Human immunodeficiency virus (HIV) infection. 4) Pregnant. 5) Ongoing testing with another allograft dd-cfDNA assessment test is planned. 6) Unwilling or unable to provide informed consent. 7) Unwilling or unable to comply with study procedures.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Cedars-Sinai Medical Center
California City, California, 90048
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Ohio State University Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Corewell Health
Grand Rapids, Michigan, 49503
Baylor College of Medicine Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Columbia University Irving Medical Center
New York, New York, 10032
University of Washington
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Observational Registry Study With Sub-analysis (Patients Previously Randomized to LAMBDA 001) to Assess ProsperaTM Performance for Detection of CLAD After Lung Transplant (LAMBDA 002)
The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.
Read the detailed description
The LAMBDA 002 registry study is an observational, longitudinal, multicenter study observing patients undergoing lung transplant in one of the following two cohorts:
Cohort 1: Previously enrolled and randomized in LAMBDA 001 (transbronchial biopsy surveillance or Prospera surveillance) and enrolled at least 12 and up to 18 months post-transplant.
Cohort 2: Not previously randomized in LAMBDA 001 (may have been enrolled but randomization did not occur), Prospera testing is part of clinical care and enrolled during less than or equal to 12 months posttransplant.
Primary Objective:
The primary objective of the study is to assess the clinical utility of combining Prospera testing with routine transplant management in detecting acute rejection or infection events in patients receiving Prospera testing as part of their post-transplant clinical care.
Secondary Objectives:
The secondary objectives of the study are to:
- Determine whether Prospera can detect AR (acute rejection) and/or infection earlier than standard clinical indicators used concurrently during the study.
- Evaluate Prospera's ability to differentiate between rejection and infectious injuries for single and repeat episodes of bacterial, viral, mycobacterial and fungal infections.
- Evaluate changes in Prospera dd-cfDNA as an indicator for biopsy proven acute rejection (BPAR), graft failure, death, development of donor-specific antibodies (DSA), chronic lung allograft dysfunction (CLAD), infection episodes and response to treatment for rejection.
- Evaluate changes in Prospera dd-cfDNA in assessments involving standard management for acute rejection and infection events.
- Conditions
- Lung Transplant Rejection
- Being tested
- Prospera
- Keywords
- Prospera, Lung Transplant, Rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProsperaDevice
Prospera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of donor derived cell-free DNA (dd-cfDNA) in the patient's blood, without the need for prior donor or recipient genotyping.
Prospera is a commercially available Laboratory Developed Test (LDT) certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 1) Cohort 1: Previously enrolled AND randomized in LAMBDA 001 Participants enrolled to Cohort 1 will be enrolled at least 12 and up to 18 months post-transplant. Receives: Device: Prospera | |
| Cohort 2 | 2) Cohort 2: Not previously randomized in LAMBDA 001 Participants who were enrolled in LAMBDA 001 but who were not randomized in LAMBDA 001 may be enrolled to Cohort 2. Receives: Device: Prospera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start4 Nov 2022
- Primary completionAug 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Ross, MD, Principal investigator, Natera, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170425
- Sponsor's protocol ID
- 21-055-TRP
- Status last verified
- May 2025
- First submitted
- 10 Dec 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry Study With Sub-analysis (Patients Previously Randomized to LAMBDA 001) to Assess ProsperaTM Performance for Detection of CLAD After Lung Transplant (LAMBDA 002)
- ClinicalTrials.gov ID
- NCT05170425
- Acronym / sponsor ID
- 21-055-TRP
- Conditions
- Lung Transplant Rejection
- Keywords
- Prospera, Lung Transplant, Rejection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.
Detailed description
The LAMBDA 002 registry study is an observational, longitudinal, multicenter study observing patients undergoing lung transplant in one of the following two cohorts:
Cohort 1: Previously enrolled and randomized in LAMBDA 001 (transbronchial biopsy surveillance or Prospera surveillance) and enrolled at least 12 and up to 18 months post-transplant.
Cohort 2: Not previously randomized in LAMBDA 001 (may have been enrolled but randomization did not occur), Prospera testing is part of clinical care and enrolled during less than or equal to 12 months posttransplant.
Primary Objective:
The primary objective of the study is to assess the clinical utility of combining Prospera testing with routine transplant management in detecting acute rejection or infection events in patients receiving Prospera testing as part of their post-transplant clinical care.
Secondary Objectives:
The secondary objectives of the study are to:
- Determine whether Prospera can detect AR (acute rejection) and/or infection earlier than standard clinical indicators used concurrently during the study.
- Evaluate Prospera's ability to differentiate between rejection and infectious injuries for single and repeat episodes of bacterial, viral, mycobacterial and fungal infections.
- Evaluate changes in Prospera dd-cfDNA as an indicator for biopsy proven acute rejection (BPAR), graft failure, death, development of donor-specific antibodies (DSA), chronic lung allograft dysfunction (CLAD), infection episodes and response to treatment for rejection.
- Evaluate changes in Prospera dd-cfDNA in assessments involving standard management for acute rejection and infection events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Prospera1) Cohort 1: Previously enrolled AND randomized in LAMBDA 001 Participants enrolled to Cohort 1 will be enrolled at least 12 and up to 18 months post-transplant. |
| Cohort 2 | – | Device: Prospera2) Cohort 2: Not previously randomized in LAMBDA 001 Participants who were enrolled in LAMBDA 001 but who were not randomized in LAMBDA 001 may be enrolled to Cohort 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung Transplantation Patient
Key inclusion criteria (4 listed)
- Age 18 or older at the time of enrollment.
- Underwent a first single or bilateral deceased-donor lung transplant. 3) Allograft was from a genetically different donor (e.g., not an identical twin).
- Cohort 1: i) Previously enrolled and randomized in LAMBDA 001 (TBBx surveillance or Prospera surveillance) AND ii) Enrolled at least 12 and up to 18 months post-transplant b) Cohort 2: i) Not previously randomized in LAMBDA 001 (may have been enrolled if randomization did not occur) AND ii) Enrolled less than or equal to 12 months post-transplant 5) Prospera testing is planned as part of routine post-transplant management.
Key exclusion criteria (3 listed)
- 1) Recipient of multi-organ transplant at the time of lung transplant. 2) Prior recipient of any solid organ or hematopoietic (bone marrow or stem cell) transplant.
- 3) Human immunodeficiency virus (HIV) infection. 4) Pregnant. 5) Ongoing testing with another allograft dd-cfDNA assessment test is planned. 6) Unwilling or unable to provide informed consent. 7) Unwilling or unable to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProsperaProspera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of donor derived cell-free DNA (dd-cfDNA) in the patient's blood, without the need for prior donor or recipient genotyping. Prospera is a commercially available Laboratory Developed Test (LDT) certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). | Device | Cohort 1, Cohort 2 |
Primary outcome
Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Related trials for Lung Transplant Rejection
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Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
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RecruitingPhase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
RecruitingPhase 1
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody Mediated Rejection of Lung Transplant
RecruitingPhase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Lung Transplant
RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ross, MD principal investigator
Natera, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Rejection, run by Natera, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.