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Transthyretin Stabilizer

Tafamidis for Transthyretin Amyloid Cardiomyopathy

Phase 4

Recruiting

Led By Justin Grodin, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a stable immunosuppressive regimen and ≤ 10 mg of prednisone (or equivalent) at time of enrollment.

Has a Karnofsky performance status ≥ 70%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 9, and 12 months

Awards & highlights

Study Summary

This trial will study the safety and efficacy of tafamidis in patients who have undergone heart or combined heart/liver transplantation for ATTR cardiac amyloidosis. The primary endpoint of this study will be serial change in plasma transthyretin (TTR) levels from baseline to 12 months.

Who is the study for?

This trial is for patients who've had a heart transplant at least 12 months ago due to end-stage Transthyretin Amyloid Cardiomyopathy (ATTR-CA). They should be relatively healthy otherwise, with stable organ function and not taking high doses of immune-suppressing drugs. People with active cancers (except certain skin cancers), infections like hepatitis or HIV, severe heart issues post-transplant, recent rejection treatments, very poor kidney function, or other types of amyloidosis can't join.Check my eligibility

What is being tested?

The study tests Tafamidis 61 MG's safety and effectiveness in patients after a heart transplant due to ATTR-CA. It's a single-arm trial where all participants receive the drug—no placebo group—focusing on how it affects protein levels related to ATTR-CA over one year and its impact on nerve health, body mass index changes, specific side effects related to the transplant, and how the body processes the drug.See study design

What are the potential side effects?

While specific side effects are not listed here, this study will closely monitor any adverse events that may arise from taking Tafamidis post-heart transplantation. These could include potential impacts on gastrointestinal health and nerves among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a stable medication regimen for my immune system, taking 10 mg or less of prednisone.

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I am mostly able to care for myself and carry out daily activities.

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I had a heart transplant over a year ago due to advanced ATTR.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serial change from baseline in plasma TTR levels at 12 months

Secondary outcome measures

Number of hepatic or renal transplant-specific adverse events

Number of transplant-specific adverse events

Serial change from baseline in Composite Autonomic Symptom Score (COMPASS-31) at12 months

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Tafamidis 61 mg

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,750 Total Patients Enrolled

Justin Grodin, MDPrincipal InvestigatorUT Southwestern Medical Center

Media Library

Tafamidis (Transthyretin Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT05489523 — Phase 4

Transthyretin Amyloid Cardiomyopathy Research Study Groups: Treatment Arm

Transthyretin Amyloid Cardiomyopathy Clinical Trial 2023: Tafamidis Highlights & Side Effects. Trial Name: NCT05489523 — Phase 4

Tafamidis (Transthyretin Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05489523 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse reactions should patients be aware of when taking Tafamidis 61 MG?

"The level of safety associated with Tafamidis 61 MG is assessed as a 3, due to its confirmation into Phase 4 trials and subsequent approval."

Answered by AI

Does this trial extend to individuals over the age of thirty?

"The accepted range of ages for this study is 18 to 90 years old. Additionally, there are two studies open to people younger than 18 and 97 trials devoted to those over 65."

Answered by AI

Are there any openings to participate in this research?

"As per the information found on clinicaltrials.gov, this specific trial has ceased to recruit patients as of October 31st 2022. The original posting was made December 15th 2022. However, fortunately there are still 97 other trials that require participants at present time."

Answered by AI

Is participation in this research study open to enrollment?

"To qualify for this trial, participants must have a diagnosis of transthyretin cardiac amyloidosis and be within the age range 18 to 90. Approximately 25 individuals will eventually enter into this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation

Justin Grodin 2023. "Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05489523.

All > Amyloidosis