NCT00551603: Withdrawn VAES dialysis protocol and mismatched GAIN paper

There is a genuine identifier discrepancy requiring explicit separation of two studies. The registry describes the Romanian VAES anemia protocol: a planned study of 300 hemodialysis patients comparing epoetin beta and darbepoetin schedules and assessing hemoglobin maintenance and dose requirements. Its December 2017 update lists withdrawal. 1 2

Separately, the original GAIN publication lists NCT00551603, but reports an international observational epoetin-beta cohort of 4,264 hemodialysis patients, not the Romanian comparative protocol. That publication describes an increase from 57% to 62% in patients within its target hemoglobin range over follow-up and lower subcutaneous than intravenous dose requirements. 3

These GAIN findings belong to the publication as described; they cannot safely be assigned to the withdrawn VAES protocol merely because the article prints the same identifier. Sponsor, design, sample size, and registry history conflict. The exact-ID query is therefore answerable only with this identity warning, not a merged efficacy claim. 1 2 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00551603. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00551603. Original study registration: sponsor, design, population, endpoints and dated history.

3. PubMed — Rath et al.: GAIN publication carrying the conflicting identifierResearch publication · Publication abstract read via Europe PMC; identifier and title cross-checked. Checked 2026-10-10. Full paper was not independently re-read for this update; abstract details should not be extended beyond what it reports.