METHUSELAH ARCHIVE SOURCES / TPE-IVIG-TRIAL-REGISTRATION

ClinicalTrials.gov registration NCT06534450

primary document · 2024
type:primary document
year:2024
citation:Clinical trial registration: NCT06534450. 'Multi-omics Analysis on Plasma Exchange.' Buck Institute for Research on Aging in collaboration with Circulate Health. Diagnostic Investigational Review Board. Registered on ClinicalTrials.gov in 2024 ahead of trial completion.
LINK
https://clinicaltrials.gov/
SUMMARY
Pre-registration of the central clinical trial that subsequently produced the *Aging Cell* publication (Fuentealba et al, 2025). The registration documents the pre-specified primary and secondary endpoints, study design (single-blind, randomized, placebo-controlled, four-arm), sample size target, and analysis plan. Pre-registration is a methodological strength that constrains post-hoc analytical flexibility and allows verification that the reported analyses were planned rather than data-driven. The registration ID NCT06534450 should be the starting point for any independent assessment of the trial's pre-specified vs. published endpoints.
NOTES

The ClinicalTrials.gov registration is the canonical pre-specification document for the TPE-IVIG trial. It is the appropriate reference for any methodological evaluation of the trial that needs to verify which endpoints were pre-specified versus added during analysis. The registration is independent of the publishing sponsor and is publicly accessible.