ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial — ALCHEMIST  

End Stage Renal Failure on Dialysis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

• NCT number: NCT01848639
• Study type: Interventional
• Source: University Hospital, Brest
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Completion date: November 2022