ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

Last updated: October 5, 2023
Sponsor: University Hospital, Brest
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Placebo

Spironolactone

Clinical Study ID

NCT01848639
ALCHEMIST
RB 12-079
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent.
  • Adult men and women on HD for at least 45 days for ESRD regardless of the etiologyincluding diabetes, with at least 3 HD sessions per week
  • Presenting at least one of the follow comorbidities, cardiovascular abnormalities orCV 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 Left bundle branch block (ECG) measured during the twelve months precedinginclusion; diabetes;
  • OR history of cardiovascular disease: coronary artery disease, symptomatic lower limbperipheral arterial disease, carotid or renal artery stenosis > 50%, stroke,hospitalization for heart failure, permanent atrial fibrillation (AF), oralanticoagulant treatment for AF, valvular heart prosthesis,
  • OR CRP > 5 mg/l for 3 months without infectious or neoplastic disease documented inprogress

Exclusion

Exclusion Criteria:

  • 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 renininhibitor (each being authorized separately), NSAIDS, Cox-2 inhibitors
  • kidney transplant scheduled within the year
  • symptomatic interdialytic hypotension
  • acute systemic disease
  • uncompensated hypothyroidism
  • acute hyperthyroidism
  • any prior or concomitant clinical condition compromising the inclusion, in thediscretion of the investigator
  • cardiac transplant
  • severe uncontrolled arrhythmia
  • stroke within 3 months prior to enrolment
  • acute coronary syndrome in the previous month inclusion
  • recent (1 month) or planned coronary revascularization by angioplasty
  • recent (3 months) or planned cardiovascular surgery (excluding HD vascular access)
  • non menopausal women or without effective contraceptive methods
  • pregnancy, breastfeeding or planning a pregnancy within 2 years
  • non compliance
  • protected adult
  • SBP > 200 mmHg and/or DBP > 110 mmHg
  • Concomitant treatment can not be stopped by another potassium-sparing diuretic, apotassium supplements, AINS or Cox 2 inhibitors

Study Design

Total Participants: 823
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 01, 2013
Estimated Completion Date:
November 30, 2022

Study 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.

Connect with a study center

  • Hôpital Erasme- Bruxelles

    Bruxelles, 1070
    Belgium

    Site Not Available

  • CH Ardeche Nord

    Annonay, Ardeche 07100
    France

    Site Not Available

  • CHU Amiens

    Amiens, 80054
    France

    Site Not Available

  • CH Avignon

    Avignon, 84000
    France

    Site Not Available

  • CHU Besançon

    Besançon, 25000
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33076
    France

    Site Not Available

  • CH Boulogne Sur Mer

    Boulogne Sur Mer, 62321
    France

    Site Not Available

  • CHRU Brest

    Brest, 29609
    France

    Site Not Available

  • CHU Caen

    Caen, 14033
    France

    Site Not Available

  • CH Cahors

    Cahors, 46000
    France

    Site Not Available

  • CHLM Castelneau

    Castelneau Le Lez, 34170
    France

    Site Not Available

  • CH Chambéry

    Chambéry, 73000
    France

    Site Not Available

  • CHPC Cherbourg

    Cherbourg, 50100
    France

    Site Not Available

  • AURAL Colmar

    Colmar, 68000
    France

    Site Not Available

  • Hopitaux Civils de Colmar

    Colmar, 68024
    France

    Site Not Available

  • APHP Henri Mondor

    Créteil, 94010
    France

    Site Not Available

  • CHU Dijon Hôpital du Bocage

    Dijon, 21079
    France

    Site Not Available

  • AGDUC Grenoble

    Grenoble, 38043
    France

    Site Not Available

  • AURAL Haguenau

    Haguenau, 67500
    France

    Site Not Available

  • CH Haguenau

    Haguenau, 67500
    France

    Site Not Available

  • La Roche Sur Yon

    La Roche Sur Yon, 85000
    France

    Site Not Available

  • Polyclinique de Lagny

    Lagny, 77400
    France

    Site Not Available

  • CHU Lille

    Lille, 59037
    France

    Site Not Available

  • Clinique Lille

    Lille, 59000
    France

    Site Not Available

  • ALURAD Limoges

    Limoges, 87000
    France

    Site Not Available

  • CHU Limoges

    Limoges, 87042
    France

    Site Not Available

  • CHG Lisieux

    Lisieux, 14100
    France

    Site Not Available

  • AURAL La Croix Rousse

    Lyon, 69004
    France

    Site Not Available

  • AURAL Lyon

    Lyon, 69008
    France

    Site Not Available

  • CH St Joseph-St Luc

    Lyon, 69007
    France

    Site Not Available

  • CHU de Lyon

    Lyon, 69003
    France

    Site Not Available

  • APHM Marseille

    Marseille, 13385
    France

    Site Not Available

  • Adpc Marseille

    Marseille, 13009
    France

    Site Not Available

  • Clinique Bouchard

    Marseille, 13006
    France

    Site Not Available

  • Clinique du pont Allant

    Maubeuge, 59604
    France

    Site Not Available

  • ALTIR Metz

    Metz, 58085
    France

    Site Not Available

  • Association de Metz

    Metz, 57000
    France

    Site Not Available

  • CHR Metz-Thionville

    Metz, 58085
    France

    Site Not Available

  • AURAL Mulhouse

    Mulhouse, 68100
    France

    Site Not Available

  • CH Mulhouse

    Mulhouse, 68100
    France

    Site Not Available

  • CHU Nancy

    Nancy, 54500
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU Nice

    Nice, 06002
    France

    Site Not Available

  • Clinique St Georges

    Nice, 06100
    France

    Site Not Available

  • CHU Nîmes

    Nîmes, 30029
    France

    Site Not Available

  • AP-HP La Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • AP-HP Necker

    Paris, 75743
    France

    Site Not Available

  • AURA Paris 14ème

    Paris, 75014
    France

    Site Not Available

  • AURA Paris Plaisance

    Paris, 75014
    France

    Site Not Available

  • Hôpital Tenon

    Paris, 75020
    France

    Site Not Available

  • Institut Mutualiste Montsouris

    Paris,
    France

    Site Not Available

  • CHU Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • AUB Morlaix

    Plourin Lès Morlaix, 29600
    France

    Site Not Available

  • ARPDD Reims

    Reims, 51726
    France

    Site Not Available

  • CHU de Reims

    Reims, 51100
    France

    Site Not Available

  • CHU Rennes

    Rennes, 35000
    France

    Site Not Available

  • ECHO Confluent

    Reze, 44402
    France

    Site Not Available

  • Centre de Perharidy

    Roscoff, 29260
    France

    Site Not Available

  • CH Roubaix

    Roubaix, 59056
    France

    Site Not Available

  • CHU Rouen

    Rouen, 76031
    France

    Site Not Available

  • CHU de la Réunion Hôpital Félix Guyon

    Saint Denis, 97405
    France

    Site Not Available

  • CH Mémorial Saint Lô

    Saint Lô, 50000
    France

    Site Not Available

  • Aub Saint Malo

    Saint Malo, 35400
    France

    Site Not Available

  • Ch Saint Malo

    Saint-Malo, 35403
    France

    Site Not Available

  • CHG St Brieuc

    St Brieuc, 22000
    France

    Site Not Available

  • Nephrocare Tassin-Charcot

    St Foy-les-lyon, 69110
    France

    Site Not Available

  • CH St Maurice

    St Maurice, 94410
    France

    Site Not Available

  • Clinique St Ouen

    St Ouen, 93400
    France

    Site Not Available

  • AURAL St Anne (AURAL Strasbourg)

    Strasbourg, 67000
    France

    Site Not Available

  • AURAL Strasbourg

    Strasbourg, 67200
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg, 67000
    France

    Site Not Available

  • Clinique Sainte Anne

    Strasbourg, 67000
    France

    Site Not Available

  • CHU Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • CHU Tours

    Tours, 37000
    France

    Site Not Available

  • CH Troyes

    Troyes, 10003
    France

    Site Not Available

  • CH Valence

    Valence, 26000
    France

    Site Not Available

  • CH Valenciennes

    Valenciennes, 59322
    France

    Site Not Available

  • ALTIR Nancy

    Vandoeuvre les Nancy, 54504
    France

    Site Not Available

  • Hôpitaux Privés de Metz- Hôpital Robert Schuman

    Vantoux, 57070
    France

    Site Not Available

  • CH Verdun

    Verdun, 55107
    France

    Site Not Available

  • CH Vichy

    Vichy, 03201
    France

    Site Not Available

  • Clinique de Choisy

    Gosier, 97190
    Guadeloupe

    Site Not Available

  • Hopital du Lamentin Martinique

    Le Lamentin, 97232
    Martinique

    Site Not Available

  • CH Princesse Grace

    Monaco,
    Monaco

    Site Not Available

  • CHU Vaudois

    Lausanne,
    Switzerland

    Site Not Available

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