ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial

• Register: EUCTR
• Last refreshed on: 24 June 2013
• Main ID: EUCTR2012-002856-18-FR
• Date of registration: 14/06/2013
• Prospective Registration: No
• 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: 22/03/2013
• 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

Countries of recruitment

France

Contacts

• Name: Valentine GUITON
• Affiliation: CHRU de Brest

• Name: Valentine GUITON
• Affiliation: CHRU de Brest

Key inclusion & exclusion criteria

Inclusion criteria:
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:


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

Health Condition(s) or Problem(s) studied

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

MedDRA version: 14.1 Level: LLT Classification code 10050441 Term: Chronic renal insufficiency System Organ Class: 100000004857
MedDRA version: 14.1 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders

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 (COOPER: coopération pharmaceutique française)
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)

Main Objective:

Primary end point(s):

Secondary Objective:

Secondary ID(s)

RB12.079

Source(s) of Monetary Support

French health ministry