CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 823 enrolled
Drug / intervention
Spironolactone +1 moredrug
Likely dose
Spironolactone 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01848639
NCT01848639Phase 3Completed
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ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b

University Hospital, Brest·interventional·Posted May 7, 2013·Updated Oct 10, 2023

In Brief

A Phase 3 clinical trial evaluating Spironolactone and Placebo for End Stage Renal Failure on Dialysis. Completed, enrolled 823 participants across 70 sites in 3 countries.

Detailed Summary

This study is designed to etablish the effects of spironolactone in comparison to placebo on the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The primary endpoint will be the time to onset of the first incident.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Failure on Dialysis
CountriesBelgium, France, Monaco
CollaboratorsCentral Hospital, Nancy, France, Institut National de la Santé Et de la Recherche Médicale, France

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2013
Enrollment StartJun 1, 2013
Primary CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 13.2 years ago

Interventions

Spironolactonedrug

After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to spironolactone. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.

Placebodrug

After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to placebo. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.