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ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

Information source: University Hospital, Brest
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Failure on Dialysis

Intervention: Spironolactone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospital, Brest

Overall contact:
Patrick ROSSIGNOL, Pr, Phone: +33383157320, Email: p.rossignol@chu-nancy.fr

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 Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

The cumulate rate of non fatal MI or acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or CV death

The time to onset of death from i) any cause and ii) from a CV event and iii) from a non CV cause

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)

Incidence of procedures related to stenosis or vascular access thrombosis for hemodialysis (HD)

Incidence of coronary or peripheral revascularizations (including lower limb amputations)

Blood pressure and its inter visit variability

The occurrence of atrial fibrillation

Incidence of hyperkalemia> 6 mmol/l

Estimation of the effect of treatment on quality of life.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Written informed consent

- Health insurance beneficiary

- Men and women, on hemodialysis for at least 6 months for end-stage renal disease

regardless of the aetiology including diabetes, with at least 3 hemodialysis sessions per week AND presenting at least one of following comorbidities or CV risk factors:

- left ventricular mass > 130 g/m2 in men and 100 g/m2 in women measured during the

twelve months preceding inclusion

- left ventricular ejection fraction < 40% measured during the twelve months preceding

inclusion

- diabetes

- history of Cardiovascular disease: coronary artery disease, symptomatic lower limb

peripheral arterial disease, carotid or renal artery stenosis > 50%, stroke, hospitalization for heart failure. 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 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

- any prior or concomitant clinical condition compromising the inclusion, in the

discretion of the investigator

- cardiac transplant

- severe uncontrolled arrhythmia

- stroke or acute coronary syndrome within 3 months prior to enrolment

- recent (3 months) or planned coronary revascularization or 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, a

potassium supplements, AINS or Cox 2 inhibitors

Locations and Contacts

Patrick ROSSIGNOL, Pr, Phone: +33383157320, Email: p.rossignol@chu-nancy.fr

CHU Amiens, Amiens 80054, France; Not yet recruiting
Gabriel CHOUKROUN, PUPH
Gabriel CHOUKROUN, PUPH, Principal Investigator

CH Avignon, Avignon 84000, France; Not yet recruiting
David Verhelst, PH
David Verhelst, PH, Principal Investigator

CHU Besançon, Besançon 25000, France; Recruiting
Jean-Marc Chalopin, PUPH
Jean-Marc Chalopin, PUPH, Principal Investigator

CHU Bordeaux, Bordeaux 33076, France; Terminated

CH Boulogne Sur Mer, Boulogne Sur Mer 62321, France; Recruiting
Pierre Bataille, PH
Pierre Bataille, PH, Principal Investigator

CHRU Brest, Brest 29609, France; Recruiting
Yannick Le Meur, PUPH
Yannick Le Meur, PUPH, Principal Investigator

CHU Caen, Caen 14033, France; Recruiting
Patrick Henri, PH
Patrick Henri, PH, Principal Investigator

CH Cahors, Cahors 46000, France; Recruiting
Etienne GED, PUPH
Etienne GED, PUPH, Principal Investigator

CH Chambéry, Chambéry 73000, France; Recruiting
Jacques Fourcade, PH
Jacques Fourcade, PH, Principal Investigator

CHPC Cherbourg, Cherbourg 50100, France; Recruiting
Guillaume Queffeulou, MD
Guillaume Queffeulou, MD, Principal Investigator

AURAL Colmar, Colmar 68000, France; Recruiting
Manfred Ismer
Manfred Ismer, Principal Investigator

Hopitaux Civils de Colmar, Colmar 68024, France; Recruiting
Mehadji Maaz, PH
Mehadji Maaz, PH, Principal Investigator

CHU Dijon Hôpital du Bocage, Dijon 21079, France; Recruiting
Jean-Michel Rebidou, MD
Jean-Michel Rebidou, MD, Principal Investigator

AGDUC Grenoble, Grenoble 38043, France; Recruiting
Philippe Zaoui, PUPH
Philippe Zaoui, PUPH, Principal Investigator

AURAL Haguenau, Haguenau 67500, France; Recruiting
Yves Dimitrov, MD
Yves Dimitrov, MD, Principal Investigator

CH Haguenau, Haguenau 67500, France; Recruiting
Yves Dimitrov, PH
Yves Dimitrov, PH, Principal Investigator

Polyclinique de Lagny, Lagny 77400, France; Terminated

CHU Lille, Lille 59037, France; Recruiting
François Provot, PH
François Provot, PH, Principal Investigator

Clinique Lille, Lille 59000, France; Recruiting
Franck Bourdon, PH
Franck Bourdon, PH, Principal Investigator

ALURAD Limoges, Limoges 87000, France; Recruiting
Carine ACHARD-HOTTELART, PH
Carine ACHARD-HOTTELART, PH, Principal Investigator

CHU Limoges, Limoges 87042, France; Recruiting
Marie Essig, PUPH
Marie Essig, PUPH, Principal Investigator

CHG Lisieux, Lisieux 14100, France; Withdrawn

AURAL La Croix Rousse, Lyon 69004, France; Recruiting
Myriam Pastural
Myriam Pastural, Principal Investigator

AURAL Lyon, Lyon 69008, France; Recruiting
Walid Arkouche, PH
Walid Arkouche, PH, Principal Investigator

CH St Joseph-St Luc, Lyon 69007, France; Not yet recruiting
Emmanuel Villar, PH
Emmanuel Villar, PH, Principal Investigator

CHU de Lyon, Lyon 69003, France; Recruiting
Emilie Kalbacher, PUPH
Emilie Kalbacher, PUPH, Principal Investigator

APHM Marseille, Marseille 13385, France; Recruiting
Marion Sallee, Dr
Marion Sallee, Dr, Principal Investigator

Clinique Bouchard, Marseille 13006, France; Not yet recruiting
Philippe GIAIME
Philippe Giaime, Principal Investigator

Clinique Marseille, Marseille 13008, France; Terminated

Clinique du pont Allant, Maubeuge 59604, France; Not yet recruiting
Christian Lamotte
Christian Lamotte, Principal Investigator

ALTIR Metz, Metz 58085, France; Recruiting
Catherine Allard
Catherine Allard, Principal Investigator

Association de Metz, Metz 57000, France; Terminated

CHR Metz-Thionville, Metz 58085, France; Recruiting
Zead Tubail
Zead Tubail, Principal Investigator

AURAL Mulhouse, Mulhouse 68100, France; Recruiting
François Chantrel, PH
François Chantrel, PH, Principal Investigator

CH Mulhouse, Mulhouse 68100, France; Recruiting
François Chantrel, PH
François Chantrel, PH, Principal Investigator

CHU Nancy, Nancy 54500, France; Recruiting
Luc Frimat, PUPH
Luc Frimat, PUPH, Principal Investigator

Polyclinique de Nancy, Nancy 54100, France; Terminated

CHU Nantes, Nantes 44093, France; Recruiting
Frédéric Lavainne, PH
Frédéric Lavainne, PH, Principal Investigator

CHU Nice, Nice 06002, France; Recruiting
Vincent Esnault, PUPH
Vincent Esnault, PUPH, Principal Investigator

Clinique St Georges, Nice 06100, France; Not yet recruiting
Jean-Christophe Bendini
Jean-Christophe Bendini, Principal Investigator

AP-HP La Salpêtrière, Paris 75013, France; Suspended

AP-HP Necker, Paris 75743, France; Recruiting
Aurélie Hummel, PH
Aurélie Hummel, PH, Principal Investigator

AURA Paris 14ème, Paris 75014, France; Terminated

AURA Paris Plaisance, Paris 75014, France; Recruiting
Caroline Creput, MD
Caroline Creput, MD, Principal Investigator

Hôpital Tenon, Paris 75020, France; Recruiting
Hafedh Fessi, MD
Hefedh Fessi, MD, Principal Investigator

CHU Lyon Sud, Pierre-Bénite 69495, France; Recruiting
Solenne Pelletier, PUPH
Solenne Pelletier, PUPH, Principal Investigator

ARPDD Reims, Reims 51726, France; Recruiting
Pierre Clavel, Dr
Pierre Clavel, Dr, Principal Investigator

CHU de Reims, Reims 51100, France; Terminated

AUB Rennes, Rennes 35000, France; Not yet recruiting
Eric Laruelle, PH
Eric Laruelle, PH, Principal Investigator

CHU Rennes, Rennes 35000, France; Recruiting
Cécile Vigneau, PUPH
Cécile Vigneau, PUPH, Principal Investigator

ECHO Confluent, Reze 44402, France; Recruiting
Angelo Testa, PH
Angelo Testa, PH, Principal Investigator

Centre de Perharidy, Roscoff 29260, France; Recruiting
Sonia Mzoughi, Dr
Sonia Mzoughi, Dr, Principal Investigator

CH Roubaix, Roubaix 59056, France; Not yet recruiting
Thomas Guincestre
Thomas Guincestre, Principal Investigator

CHU de la Réunion Hôpital Félix Guyon, Saint Denis 97405, France; Recruiting
Anne-Hélène Reboux, MD
Anne-Hélène Reboux, MD, Principal Investigator

CH Mémorial Saint Lô, Saint Lô 50000, France; Not yet recruiting
Thibault Besselievre, MD
Thibault Besselievre, MD, Principal Investigator

CHG St Brieuc, St Brieuc 22000, France; Recruiting
Rehouni Boulahrouz, PH
Rehouni Boulahrouz, PH, Principal Investigator

CH St Maurice, St Maurice 94410, France; Terminated

AURAL Strasbourg, Strasbourg 67200, France; Not yet recruiting
Kristian Kunz, PH
Kristian Kunz, PH, Principal Investigator

CHU Strasbourg, Strasbourg 67000, France; Recruiting
Thierry Hannedouche, PUPH
Thierry Hannedouche, PUPH, Principal Investigator

CHU Toulouse, Toulouse 31059, France; Recruiting
Lionel Rostaing, PUPH
Lionel Rostaing, PUPH, Principal Investigator

CHU Tours, Tours 37000, France; Recruiting
Maud Francois, PH
Maud Francois, PH, Principal Investigator

CH Troyes, Troyes 10003, France; Not yet recruiting
Bénédicte Levy
Bénédicte Levy, Principal Investigator

CH Valenciennes, Valenciennes 59322, France; Not yet recruiting
Mary-Jane Guerry
Mary-Jane Guerry, Principal Investigator

ALTIR Nancy, Vandoeuvre les Nancy 54504, France; Recruiting
Nelly Castin, PH
Nelly Castin, PH, Principal Investigator

Hôpitaux Privés de Metz- Hôpital Robert Schuman, Vantoux 57070, France; Terminated

CH Verdun, Verdun 55107, France; Recruiting
Pascal Bindi, PH
Pascal Bindi, PH, Principal Investigator

CH Vichy, Vichy 03201, France; Not yet recruiting
Didier Aguilera
Didier Aguilera, Principal Investigator

Clinique de Choisy, Gosier 97190, Guadeloupe; Terminated

CH Ardeche Nord, Annonay, Ardeche 07100, France; Recruiting
Eric LEGRAND, PH
Eric Legrand, PH, Principal Investigator

Additional Information

Starting date: June 2013
Last updated: June 29, 2015

Page last updated: August 23, 2015

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