Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062561) titled 'Validation of Transthyretin Concentration in the Treatment of Transthyretin Amyloidosis' on Aug. 12.
Study Type:
Observational
Primary Sponsor:
Institute - Shinshu University
Condition:
Condition - Wild type transthyretin amyloidosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Wild-type transthyretin amyloidosis (ATTRwt amyloidosis), caused by the age-related destabilization of the transthyretin (TTR) tetramer, has has garnered significant attention in aging societies. The advent of disease-modifying therapies for ATTR amyloidosis, such as TTR stabilizers, offers effective treatment but has simultaneously sparked debate regarding the appropriate TTR concentration to target during therapy. This study focused on the underlying clinical factors contributing to the increase in TTR concentration after the initiation of tafamidis treatment.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Retrospective study involving all patients with ATTRwt amyloidosis who initiated oral tafamidis treatment at Shinshu University Hospital between September 2019 and September 2025.Patients were retrospectively enrolled if they had documented serum TTR concentration measurements both before (baseline) and 1 year after the initiation of tafamidis.
Key exclusion criteria - Exclusion criteria included the absence of both pre- and 1-year post-treatment serum TTR measurements and cases lost to follow-up.
Target Size - 60
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 11 Month 06 Day
Date of IRB - 2025 Year 11 Month 06 Day
Anticipated trial start date - 2025 Year 11 Month 06 Day
Last follow-up date - 2025 Year 11 Month 23 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068279
Disclaimer: Curated by HT Syndication.