ClinicalTrials.gov registration NCT06534450
primary document · 2024
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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.