NCT05489523
Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation
Active, Not Recruiting
PHASE4Ages 18–90InterventionalTreatmentUniversity of Texas Southwestern Medical CenterInvestigator-initiated
~25 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Tafamidis 61 MG
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serial change from baseline in plasma TTR levels at 12 months
Measured over Baseline, 3, 6, 9, and 12 months
Conditions
Where it's being run
4 sites across 4 statesCalifornia1
New York1
Ohio1
Texas1
Study leadership
- Justin Grodin, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
- Jan Griffin, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Has received orthotopic heart transplantation for end-stage ATTRv or ATTRwt ≥12 months prior to screening. Concomitant hepatic and renal transplantation with adequate allograft function are included.
Has a stable immunosuppressive regimen and ≤ 10 mg of prednisone (or equivalent) at time of enrollment.
Has a Karnofsky performance status ≥ 70%
Exclusion
Has previously received inotersen within the past 180 days, patisiran within the past 90 days, tafamidis within the past 14 days, or diflunisal in the past 14 days.
Participating in a clinical trial for ATTR targeted therapies.
Has an estimated glomerular filtration rate (eGFR) ≤ 15 ml/min/1.73 m2
Has known leptomeningeal or AL amyloidosis
Has active post-transplant lymphoproliferative disease
Excluding non-melanomatous skin cancers, has an active malignancy.
Has active infection with hepatitis B, hepatitis C, human immunodeficiency virus, or cytomegalovirus (CMV). For CMV, donor/ recipient exposure status and prior treated CMV disease on stable doses of antiviral therapies are not excluded.
Has cardiac allograft dysfunction defined by left ventricular ejection fraction (LVEF) \<50% by echocardiogram within the past 3 months
Has been treated for acute cellular or antibody mediated rejection in the past 3 months
Has criteria to meet International Society for Heart and Lung Transplantation standardized nomenclature for severe coronary allograft vasculopathy ("ISHLT CAV3")
What this trial measures
- Serial change from baseline in plasma TTR levels at 12 monthsBaseline, 3, 6, 9, and 12 months
Serial change from baseline in plasma Time in Therapeutic Range (TTR) levels at 12 months is measured at 3 month intervals. TTR tetramer stability is measured using an immunoturbidimetric assay. Increase in plasma TTR levels indicate TTR tetramer stability.