ALCHEMIST

Summary of the study :

The ALCHEMIST therapeutic trial started in June 2013 on the whole French territory with more than 60 French centres and is extending to Europe.

It aims to determine the safety and efficacy of an old and well-known drug "Spironolactone" in reducing cardiovascular risks in patients with end-stage renal disease on haemodialysis, compared to placebo.

Kidney failure is a deterioration of both kidneys, which no longer filter blood properly. It is induced by pathologies such as diabetes or hypertension, which progressively destroy the different structures of the kidney. This disease is said to be chronic when the dysfunction is irreversible and therefore without possibility of cure. However, it is possible to stabilise this insufficiency.

In France, each year, approximately 10,000 people start a replacement therapy. The total number of dialysis patients is increasing by 4% per year. According to recent studies, 10% of the general population meet the criteria for chronic kidney disease. Chronic kidney disease is therefore a public health priority.

Cardiovascular risk is the main complication of this disease. Cardiac pathology is the main cause of mortality in haemodialysis patients ( 42% of total mortality).

After one month in an open-label setting with Spironolactone 25 mg every other day, administered per os in practice after the dialysis session three times a week, patients will be randomised to either the Spironolactone or placebo arm. The dose is increased to 25 mg once daily and can be adjusted using an algorithm.

 Partners/ Supporters :

Cardiovascular ICC Network

Investigation Network Initiative - Cardiovascular and Renal Clinical Trialists INI CRCT

- F-CRIN

French-speaking Society of Nephrology, Dialysis and Transplantation

- National Pedagogical Association of Therapeutic Teachers (APNET)

- Young Hypertensiologists Club

- Fresenius Medical Care

- Vifor Fresenius Medical Care Renal Pharma

- PHRC Monaco

Financing : 

- Main funding : Hospital Clinical Research Programme (Ministry of Social Affairs and Health)

- Others: Fresenius Medical Care, INSERM