Prospera for Lung Transplant Rejection

Not currently recruiting at 14 trial locations

Overseen By LAMBDA 002 Study Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Natera, Inc.

Disqualifiers: Multi-organ transplant, HIV, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe patients who have undergone a lung transplant to evaluate how well the treatment, Prospera, manages their condition over time. Participants will join one of two groups based on their previous involvement in an earlier study. Individuals who have received their first single or double lung transplant from a donor and plan to use Prospera (a monitoring test) as part of their routine care are well-suited for this trial.

As a Phase 4 trial, Prospera is already FDA-approved and proven effective. This research seeks to understand how it benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that Prospera is safe for lung transplant patients?

Research has shown that the Prospera system is safe. Studies have found that the Prospera Spinal Cord Stimulation (SCS) System is generally well-tolerated, with complications uncommon. The FDA has already approved the system for other medical uses, indicating it has passed strict safety tests.

While some side effects may occur, they are usually not serious. It's important to remember that all medical treatments carry risks, but evidence suggests that the Prospera system is generally safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Prospera because, unlike traditional treatments for lung conditions, it offers a personalized diagnostic approach by analyzing molecular markers in the blood. This method allows for early and accurate detection of lung complications, which can lead to more timely and precise interventions. By focusing on genetic and molecular indicators rather than just symptoms, Prospera has the potential to improve patient outcomes significantly by tailoring treatments to the individual's unique biological profile.

What evidence suggests that Prospera might be an effective treatment for lung transplant patients?

Research has shown that Prospera effectively monitors transplant patients. In one study, patients with low or decreasing Prospera results experienced much better outcomes a year later, suggesting Prospera's predictive ability for post-transplant success. Another study found that 18 out of 28 patients with high-risk Prospera results had confirmed active rejection, indicating Prospera's accuracy in identifying patients at risk of rejection. Overall, evidence supports Prospera as a reliable tool for assessing the health of transplant patients. Participants in this trial will join either Cohort 1 or Cohort 2, based on their previous involvement in the LAMBDA 001 study. ^{1 6 7 8 9}

Who Is on the Research Team?

David Ross, MD

Principal Investigator

Natera, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

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).

a) 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Participants are observed for clinical utility of combining Prospera testing with routine transplant management

12-18 months

Follow-up

Participants are monitored for safety and effectiveness after observational period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prospera

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

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.

Group II: Cohort 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Natera, Inc.

Lead Sponsor

Trials

56

Recruited

50,700+

Citations

1.

natera.com

natera.com/company/news/pedal-study-successful-shows-monitoring-with-prospera-kidney-provides-accurate-prognosis-of-long-term-clinical-outcomes-following-rejection-now-published-in-ajt/

PEDAL Study Successful, Shows Monitoring with Prospera ...

The odds of experiencing positive outcomes after 1 year were 60x higher among patients with low/decreasing Prospera trends. These patients were ...

2.

investor.natera.com

investor.natera.com/news/news-details/2025/Natera-Highlights-Latest-Prospera-Data-at-WTC-2025-16-Abstracts-Including-Five-Oral-Presentations/default.aspx

Natera Highlights Latest Prospera™ Data at WTC 2025

Natera Highlights Latest Prospera™ Data at WTC 2025; 16 Abstracts Including Five Oral Presentations. 08/01/2025. Download ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11729204/

A Review of the Prospera Spinal Cord Stimulation System with ...

Prospera delivers therapy using a proprietary multiphase stimulation paradigm and is the first SCS system to offer proactive care.

4.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf21/P210037B.pdf

summary of safety and effectiveness data (ssed)

The safety and effectiveness of the Prospera SCS System were based on a systematic review and meta-analysis (for safety outcomes) of published ...

5.

renalinterventions.net

renalinterventions.net/natera-announces-study-results-showing-excellent-positive-predictive-value-of-prospera-kidney-test/

Natera announces study results showing “excellent” ...

Eighteen of the 28 patients with biopsy-matched high-risk Prospera dd-cfDNA test results were confirmed to have active rejection, demonstrating ...

6.

fda.gov

fda.gov/medical-devices/recently-approved-devices/prospera-spinal-cord-stimulation-scs-system-resilience-percutaneous-lead-homestream-remote

Prospera Spinal Cord Stimulation (SCS) System ...

See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS5114

ProSperA: Phase I study to evaluate safety, tolerability and ...

This is an ongoing open label, single center phase I clinical trial evaluating CC-1 without androgen deprivation therapy as first line treatment in men with ...

8.

natera.com

natera.com/resource-library/prospera/proactive-study-data-summary/

ProActive Study Data Summary

ISHLT 2025 clinical use of DQS Roopa Rao. Dr Roopa Rao from IU Health shares her experience with 2 unique cases where Prospera Heart with DQS was key to their ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05205551

Prospera Test Evaluation in Cardiac Transplant (ProTECT)

Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...