NCT01848639

ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 823 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* During a run-in period : Spironolactone will be initially administered per os at a 25 mg dose per two days in practice after the session, three times per week * Patients will be randomized (spironolactone vs. placebo) and titrated over one month to a maximum single dose of 25 mg/d * However if kalemia is greater than or equal to 5.5 mmol / l twice on this run-in period or on the day of randomization, patient won't be randomized. * A pre-specified algorithm for the management of the risk of incident hyperkalemia will be followed, including dose adjustment, temporary cessation of study treatment, in addition to usual dietary measures and the use of chelating resins and low-potassium dialysis baths * Patients will be followed for a mean of 2 years.

Conditions

• End Stage Renal Failure on Dialysis

Interventions

Type	Name	Description
DRUG	Spironolactone	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.
DRUG	Placebo	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2013-05-07
• Last updated: 2023-10-10

Locations

70 sites across 3 countries: Belgium, France, Monaco