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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03020303




Registration number
NCT03020303
Ethics application status
Date submitted
11/01/2017
Date registered
13/01/2017

Titles & IDs
Public title
Aldosterone BloCkade for Health Improvement EValuation in End-stage Renal Disease
Scientific title
Aldosterone BloCkade for Health Improvement EValuation in End-stage Renal Disease
Secondary ID [1] 0 0
ACHIEVE Trial
Universal Trial Number (UTN)
Trial acronym
ACHIEVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endstage Renal Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Spironolactone 25Mg Tablet
Treatment: Drugs - Placebo Oral Tablet

Placebo comparator: Placebo Oral Tablet - A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance

Active comparator: Spironolactone 25 MG Tablet - 25 mg of active spironolactone in tablet form


Treatment: Drugs: Spironolactone 25Mg Tablet
Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.

Treatment: Drugs: Placebo Oral Tablet
Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CV Death or Hospitalization for Heart Failure
Timepoint [1] 0 0
up to 5 years
Secondary outcome [1] 0 0
Cause specific death
Timepoint [1] 0 0
up to 5 years
Secondary outcome [2] 0 0
Hospitalization for Heart Failure
Timepoint [2] 0 0
up to 5 years
Secondary outcome [3] 0 0
All-cause death
Timepoint [3] 0 0
up to 5 years
Secondary outcome [4] 0 0
All-cause Hospitalization
Timepoint [4] 0 0
up to 5 years
Secondary outcome [5] 0 0
Hospitalization for hyperkalemia
Timepoint [5] 0 0
up to 5 years

Eligibility
Key inclusion criteria
1. Age

1. =45 years or
2. =18 with a history of diabetes
2. On dialysis = 90 days
3. On either

1. Hemodialysis prescribed at least 2 treatments per week or
2. Peritoneal dialysis prescribed with at least 1 exchange daily
4. Provides informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hyperkalemia

1. Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or
2. Serum potassium >6.0 mmol/L during active run-in
2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).
3. Known sensitivity or allergy to spironolactone
4. Current or planned pregnancy or breastfeeding
5. Scheduled living related donor renal transplant
6. Life expectancy < 6 months in the opinion of a treating nephrologist.
7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.
8. Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
2750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Wahroonga
Recruitment hospital [5] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [6] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 0 0
Royal Brisbane Women&#39;s Hospital - Herston
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Monash Health - Clayton
Recruitment hospital [10] 0 0
Western Health - Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [4] 0 0
2076 - Wahroonga
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3021 - Saint Albans
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Bahia
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Brazil
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Belo Horizonte
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Brazil
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Botucatu
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Brazil
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Joinville
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Brazil
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Minas Gerais
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Brazil
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Parana
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Brazil
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Porto Alegre
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Brazil
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Rio Grande do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Brazil
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South Carolina
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Brazil
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Bela Vista
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Brazil
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Ponta Grossa
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Canada
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Alberta
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Canada
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British Colombia
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Canada
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British Columbia
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Ningxia
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China
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Shandong
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China
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Baotou
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Changchun
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China
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Enshi
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Kunming
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Lanzhou
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Luoyang
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Shanghai
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Shanxi
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Suqian
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Tianjin
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China
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Tongliao
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Xinxiang
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China
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Xuzhou
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China
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Yuxi
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China
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Zhongwei
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Ecuador
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Pichincha
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Chennai
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Karnataka
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Kerala
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Maharashtra
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Tamil Nadu
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Telegana
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Madurai
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Mangalore
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Nagpur
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Johor
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Kuala Terengganu
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Kuantan
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Hastings
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New Plymouth
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Palmerston North
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Whangarei
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Philippines
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Manila
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Turkey
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Ankara
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Turkey
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Eskisehir
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Turkey
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Istanbul
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United Kingdom
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Belfast
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Down
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Kent
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United Kingdom
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Oxford
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Aberdeen
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Birmingham
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Bristol
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Cardiff
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Carshalton
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Derby
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Dundee
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Glasgow
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Leicester
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Liverpool
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London
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Middlesbrough
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United Kingdom
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Nottingham
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United Kingdom
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Salford
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United Kingdom
State/province [88] 0 0
Stoke-on-Trent
Country [89] 0 0
Uruguay
State/province [89] 0 0
Cerro Largo
Country [90] 0 0
Uruguay
State/province [90] 0 0
Montevideo

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Walsh, MD, PhD
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jessica Tyrwhitt, B.A.
Address 0 0
Country 0 0
Phone 0 0
9055274322
Fax 0 0
Email 0 0
jessica.tyrwhitt@phri.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
N/A - no plan to make IPD available to other researchers


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03020303