ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial

• Register: EUCTR
• Last refreshed on: 4 December 2018
• Main ID: EUCTR2012-002856-18-BE
• Date of registration: 17/07/2015
• Prospective Registration: Yes
• Primary sponsor: CHRU de Brest
• Public title: ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial
• Scientific title: ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial - ALCHEMIST
• Date of first enrolment: 08/09/2015
• Target sample size: 825
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002856-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, France, Monaco

Contacts

• Name: Audrey Le Goff-Coquet
• Affiliation: CHRU de Brest

• Name: Audrey Le Goff-Coquet
• Affiliation: CHRU de Brest

Key inclusion & exclusion criteria

Inclusion criteria:
Men and women over the age of at least 45 days for IRCT, regardless of the etiology including diabetes, having at least 3 HD sessions per week AND having at least one of the comorbidities, cardiovascular anomalies or risk factor CV following:
Left ventricular hypertrophy defined by left ventricular mass> 130 g / m2 in men and 100 g / m2 in women, (echocardiography) OR Cornell index (RaVL + SV3)> 28 mm in humans,> 20 mm in women (electrocardiogram), or left ventricular ejection fraction <40%, (echocardiography); QRS wide> 0.14 sec OR Left branch block (electrocardiogram) measured in the 12 months prior to inclusion; diabetes; history of CV disease: coronary artery disease, symptomatic lower extremity arterial disease, renal or carotid artery stenosis> 50%, stroke, hospitalization for heart failure, permanent atrial fibrillation (AF) arrhythmia, current oral anticoagulant therapy for AF indication, valvular prosthesis cardiac or CRP> 5 mg / l for 3 months without documented infectious or neoplastic pathology AND informed written consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
History of hypersensitivity to spironolactone; 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, or 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); 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 within 3 months prior to enrolment; acute coronary syndrome within 1 month prior to enrolment; recent (1 month) or planned coronary revascularization with angioplasty; or CV surgery outside the vascular access of the HD recent (3 months) or planned; non menopausal women or without oral contraceptives; pregnancy or planning a pregnancy within 2 years; non compliance; protected adult; SBP > 200 mmHg and/or DBP > 110 mmHg;Any concomitant treatment that can not be stopped by another potassium-sparing diuretic, potassium supplementation, NSAIDs or Cox 2 inhibitors


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

end-stage renal failure (ESRF) cardiovascular complication
MedDRA version: 20.0 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 20.0 Level: LLT Classification code 10050441 Term: Chronic renal insufficiency System Organ Class: 100000004857

Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Intervention(s)

Product Name: Spironolactone
Product Code: Not applicable
Pharmaceutical Form: Capsule
INN or Proposed INN: Spironolactone + Lactose monohydraté (Pharmaceutical INRESA Pharma) + carmin de cochenille (FAGRON Services)
Other descriptive name: spironolactone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At the date of the first event or at the end of participation in the patient's test

Main Objective: To etablish the effects of spironolactone in comparison to placebo on the composite endpoint of nonfatal myocardial infarction (MI), acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or CV-induced death. The primary endpoint will be the time to onset of the first incident

Secondary Objective: a) cumulative rates of accidents component primary endpoints b) time to onset of death i) from any cause, ii) from a CV event, iii) from a non-CV event; b) time of survival without a major CV event (nonfatal MI,acute coronary syndrome, hospitalization for heart failure, non-fatal stroke, cardiac arrest resuscitation); c) incidence of procedures related to stenosis or vascular access thrombosis for HD; d) incidence of coronary or peripheral revascularizations (including lower limb amputations); e) blood pressure; f) incidence of hyperkalemia> 6 mmol/l; g) estimation of the effect of treatment on quality of life.
Two ancillary studies are planned and should be funded outside of the budget of the Hospital Clinical Research Programme (Programme Hospitalier de Recherche Clinique, PHRC 2011, which granted this protocol) : 1) medico-economic study, 2) establishment of a biological collection (serum bank and DNA biobank) for future biomarker studies.

Primary end point(s): The primary endpoint will be the time to onset of the first incident.

Secondary Outcome(s)

Secondary end point(s): a) cumulative rates of accidents component primary endpoints b) time to onset of death i) from any cause, ii) from a CV event, iii) from a non-CV event; b) time of survival without a major CV event (nonfatal MI,acute coronary syndrome, hospitalization for heart failure, non-fatal stroke, cardiac arrest resuscitation); c) incidence of procedures related to stenosis or vascular access thrombosis for HD; d) incidence of coronary or peripheral revascularizations (including lower limb amputations); e) blood pressure; f) incidence of hyperkalemia> 6 mmol/l; g) estimation of the effect of treatment on quality of life.
Two ancillary studies are planned and should be funded outside of the budget of the Hospital Clinical Research Programme (Programme Hospitalier de Recherche Clinique, PHRC 2011, which granted this protocol) : 1) medico-economic study, 2) establishment of a biological collection (serum bank and DNA biobank) for future biomarker studies.

Timepoint(s) of evaluation of this end point: each visit

Secondary ID(s)

2012-002856-18-FR

NCT01848639

RB12.079

Source(s) of Monetary Support

French health ministry