ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 16 October 2023
• Main ID: NCT01848639
• Date of registration: 03/05/2013
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Brest
• Public title: ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial ALCHEMIST
• Scientific title: ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b
• Date of first enrolment: June 2013
• Target sample size: 823
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01848639
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Belgium, France, Guadeloupe, Martinique, Monaco, Switzerland

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Left bundle branch block (ECG) measured during the twelve months preceding
inclusion; diabetes;

- 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

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 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, a
potassium supplements, AINS or Cox 2 inhibitors



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

End Stage Renal Failure on Dialysis

Intervention(s)

Drug: Placebo

Drug: Spironolactone

Primary Outcome(s)

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 [Time Frame: 25 months]

Secondary Outcome(s)

cumulative accident rates forming the primary endpoint [Time Frame: 24 months]

Incidence of coronary or peripheral revascularizations (including lower limb amputations) [Time Frame: 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) [Time Frame: 24 months]

non-cardiovascular mortality rate [Time Frame: 24 months]

The occurrence of atrial fibrillation [Time Frame: 24 months]

Estimation of the effect of treatment on quality of life. [Time Frame: 24 months]

Incidence of hyperkalemia> 6 mmol/l [Time Frame: 24 months]

Blood pressure (systolic and diastolic pressure) [Time Frame: 24 months]

Blood pressure's variability inter visit (systolic and diastolic pressure) [Time Frame: 24 months]

Determine the effects of spironolactone compared to placebo on the composite winratio endpoint [Time Frame: 24 months]

Incidence of procedures related to stenosis or vascular access thrombosis for hemodialysis (HD) [Time Frame: 24 months]

Secondary ID(s)

RB 12-079

ALCHEMIST

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut National de la Santé Et de la Recherche Médicale, France

Central Hospital, Nancy, France