ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial
ALCHEMIST
2 other identifiers
interventional
823
3 countries
70
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2013
Longer than P75 for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedOctober 10, 2023
October 1, 2023
9.4 years
May 3, 2013
October 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The time to onset of the first incident :non-fatal MI or acute coronary syndrome or hospitalization for heart failure or nonfatal stroke or cardiovascular (CV) death
25 months
Secondary Outcomes (14)
Determine the effects of spironolactone compared to placebo on the composite winratio endpoint
24 months
Determine the effects of spironolactone compared to placebo on the composite winratio endpoint
24 months
non-cardiovascular mortality rate
24 months
cumulative accident rates forming the primary endpoint
24 months
The time of survival without a major CV event (non fatal MI, acute coronary syndrome, hospitalization for heart failure, non-fatal stroke, cardiac arrest resuscitation)
24 months
- +9 more secondary outcomes
Other Outcomes (2)
Ancillary study:establishment of a biological collection (serum bank and DNA biobank) for future biomarker studies
24 months
Ancillary study:morbimortality data
3, 5 and 10 years of follow-up after the double-blind study
Study Arms (2)
Spironolactone
ACTIVE COMPARATORAfter 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.
Placebo
PLACEBO COMPARATORAfter 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Written informed consent.
- Adult men and women on HD for at least 45 days for ESRD regardless of the etiology including diabetes, with at least 3 HD sessions per week
- Presenting at least one of the follow comorbidities, cardiovascular abnormalities or CV risk factors:
- Left ventricular hypertrophy defined by left ventricular mass \> 130 g/m2 in men and 100 g/m2 in women (echocardiography)
- OR Cornell (RaVL + SV3) \>28 mm in men, \> 20 mm in women(ECG)
- OR left ventricular ejection fraction \< 40%
- OR large QRS \> 0.14 sec
- OR history of cardiovascular disease: coronary artery disease, symptomatic lower limb peripheral arterial disease, carotid or renal artery stenosis \> 50%, stroke, hospitalization for heart failure, permanent atrial fibrillation (AF), oral anticoagulant treatment for AF, valvular heart prosthesis,
- OR CRP \> 5 mg/l for 3 months without infectious or neoplastic disease documented in progress
You may not qualify if:
- history of hypersensitivity to spironolactone or galactose intolerance
- the Lapp lactase deficiency or malabsorption of glucose or galactose
- hyperkalemia \> 5.5 mmol/l during the two weeks prior to enrolment
- history of unscheduled hemodialysis for hyperkalemia during the last six months
- hospitalization for hyperkalemia during the last six months
- patients with imperative indication of a combination of ACEI and sartan or renin inhibitor (each being authorized separately), NSAIDS, Cox-2 inhibitors
- kidney transplant scheduled within the year
- symptomatic interdialytic hypotension
- acute systemic disease
- uncompensated hypothyroidism
- acute hyperthyroidism
- cardiac transplant
- severe uncontrolled arrhythmia
- stroke within 3 months prior to enrolment
- recent (1 month) or planned coronary revascularization by angioplasty
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Hôpital Erasme- Bruxelles
Brussels, 1070, Belgium
CH Ardeche Nord
Annonay, Ardeche, 07100, France
CHU Amiens
Amiens, 80054, France
CH Avignon
Avignon, 84000, France
CHU Besançon
Besançon, 25000, France
CH Boulogne Sur Mer
Boulogne-sur-Mer, 62321, France
CHRU Brest
Brest, 29609, France
CHU Caen
Caen, 14033, France
CH Cahors
Cahors, 46000, France
CH Chambéry
Chambéry, 73000, France
CHPC Cherbourg
Cherbourg, 50100, France
AURAL Colmar
Colmar, 68000, France
Hopitaux Civils de Colmar
Colmar, 68024, France
APHP Henri Mondor
Créteil, 94010, France
CHU Dijon Hôpital du Bocage
Dijon, 21079, France
AGDUC Grenoble
Grenoble, 38043, France
AURAL Haguenau
Haguenau, 67500, France
CH Haguenau
Haguenau, 67500, France
La Roche Sur Yon
La Roche-sur-Yon, 85000, France
Polyclinique de Lagny
Lagny, 77400, France
Clinique Lille
Lille, 59000, France
CHU Lille
Lille, 59037, France
ALURAD Limoges
Limoges, 87000, France
CHU Limoges
Limoges, 87042, France
CHU de Lyon
Lyon, 69003, France
AURAL La Croix Rousse
Lyon, 69004, France
CH St Joseph-St Luc
Lyon, 69007, France
AURAL Lyon
Lyon, 69008, France
Clinique Bouchard
Marseille, 13006, France
Adpc Marseille
Marseille, 13009, France
APHM Marseille
Marseille, 13385, France
Association de Metz
Metz, 57000, France
ALTIR Metz
Metz, 58085, France
CHR Metz-Thionville
Metz, 58085, France
AURAL Mulhouse
Mulhouse, 68100, France
CH Mulhouse
Mulhouse, 68100, France
CHU Nancy
Nancy, 54500, France
CHU Nantes
Nantes, 44093, France
CHU Nice
Nice, 06002, France
Clinique St Georges
Nice, 06100, France
AP-HP La Salpêtrière
Paris, 75013, France
AURA Paris 14ème
Paris, 75014, France
AURA Paris Plaisance
Paris, 75014, France
Hôpital Tenon
Paris, 75020, France
AP-HP Necker
Paris, 75743, France
Institut Mutualiste Montsouris
Paris, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
CHU de Reims
Reims, 51100, France
ARPDD Reims
Reims, 51726, France
CHU Rennes
Rennes, 35000, France
ECHO Confluent
Rezé, 44402, France
Centre de Perharidy
Roscoff, 29260, France
CH Roubaix
Roubaix, 59056, France
CHG St Brieuc
Saint-Brieuc, 22000, France
CHU de la Réunion Hôpital Félix Guyon
Saint-Denis, 97405, France
Aub Saint Malo
St-Malo, 35400, France
Ch Saint Malo
St-Malo, 35403, France
AURAL St Anne (AURAL Strasbourg)
Strasbourg, 67000, France
CHU Strasbourg
Strasbourg, 67000, France
Clinique Sainte Anne
Strasbourg, 67000, France
AURAL Strasbourg
Strasbourg, 67200, France
CHU Toulouse
Toulouse, 31059, France
CHU Tours
Tours, 37000, France
CH Troyes
Troyes, 10003, France
CH Valenciennes
Valenciennes, 59322, France
ALTIR Nancy
Vandœuvre-lès-Nancy, 54504, France
Hôpitaux Privés de Metz- Hôpital Robert Schuman
Vantoux, 57070, France
CH Verdun
Verdun, 55107, France
CH Vichy
Vichy, 03201, France
CH Princesse Grace
Monaco, Monaco
Related Publications (2)
Rossignol P, Zannad F, Massy Z, Azizi M, Chorfa F, Coadic J, Ferreira JP, Saraiva F, Mottier D, Guillemin F, Ngueyon Sime W, Bouali S, Rossignol B, Nortier J, Simon I, Robino C, Davin M, Bataille PM, Chantrel F, Castin N, Esnault V, Kazes I, Hannedouche T, Kamar N, Achard JM, Fenerol C, Achard-Hottelart C, Dimitrov Y, Girerd N, Maucort-Boulch D, Frimat L; ALCHEMIST study group. Spironolactone in patients on chronic haemodialysis at high risk of adverse cardiovascular outcomes (ALCHEMIST): a multicentre, double-blind, randomised, placebo-controlled trial and updated meta-analysis. Lancet. 2025 Aug 16;406(10504):705-718. doi: 10.1016/S0140-6736(25)01194-8.
PMID: 40818851DERIVEDHasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
PMID: 33586138DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2013
First Posted
May 7, 2013
Study Start
June 1, 2013
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
Statistical Analysis Plan