Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03020303




Registration number
NCT03020303
Ethics application status
Date submitted
11/01/2017
Date registered
13/01/2017
Date last updated
24/02/2023

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
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
1/01/2025
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'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
Country [2] 0 0
Brazil
State/province [2] 0 0
Belo Horizonte
Country [3] 0 0
Brazil
State/province [3] 0 0
Botucatu
Country [4] 0 0
Brazil
State/province [4] 0 0
Joinville
Country [5] 0 0
Brazil
State/province [5] 0 0
Minas Gerais
Country [6] 0 0
Brazil
State/province [6] 0 0
Natal
Country [7] 0 0
Brazil
State/province [7] 0 0
Parana
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio Grande Do Sul
Country [10] 0 0
Brazil
State/province [10] 0 0
Santa Catarina
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
SC
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Colombia
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
State/province [18] 0 0
Québec
Country [19] 0 0
Ecuador
State/province [19] 0 0
Pichincha
Country [20] 0 0
India
State/province [20] 0 0
Chennai
Country [21] 0 0
India
State/province [21] 0 0
Karnataka
Country [22] 0 0
India
State/province [22] 0 0
Kerala
Country [23] 0 0
India
State/province [23] 0 0
Maharashtra
Country [24] 0 0
India
State/province [24] 0 0
Tamil Nadu
Country [25] 0 0
India
State/province [25] 0 0
Telangana
Country [26] 0 0
India
State/province [26] 0 0
Telegana
Country [27] 0 0
Malaysia
State/province [27] 0 0
Johor
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lumpur
Country [29] 0 0
Malaysia
State/province [29] 0 0
Perak
Country [30] 0 0
Malaysia
State/province [30] 0 0
Pulau Pinang
Country [31] 0 0
Malaysia
State/province [31] 0 0
Selangor
Country [32] 0 0
Malaysia
State/province [32] 0 0
Kuala Terengganu
Country [33] 0 0
Malaysia
State/province [33] 0 0
Kuantan
Country [34] 0 0
Malaysia
State/province [34] 0 0
Seremban
Country [35] 0 0
Malaysia
State/province [35] 0 0
Setapak
Country [36] 0 0
New Zealand
State/province [36] 0 0
Auckland
Country [37] 0 0
New Zealand
State/province [37] 0 0
Waikato
Country [38] 0 0
New Zealand
State/province [38] 0 0
Dunedin
Country [39] 0 0
New Zealand
State/province [39] 0 0
Hastings
Country [40] 0 0
New Zealand
State/province [40] 0 0
New Plymouth
Country [41] 0 0
New Zealand
State/province [41] 0 0
Palmerston North
Country [42] 0 0
New Zealand
State/province [42] 0 0
Whangarei
Country [43] 0 0
Philippines
State/province [43] 0 0
Manila
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Belfast
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Down
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Kent
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Oxford
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Aberdeen
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Bristol
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Cardiff
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Derby
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Dundee
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Glasgow
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Nottingham
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Salford
Country [57] 0 0
Uruguay
State/province [57] 0 0
Cerro Largo
Country [58] 0 0
Uruguay
State/province [58] 0 0
Montevideo

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
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
Individuals receiving dialysis are at risk of heart failure and heart related death. There is
an urgent need for treatments that reduce the risk of these problems in patients that require
dialysis.

Spironolactone is a pill used to prevent heart failure and related deaths in patients that do
not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes
high blood pressure and can damage the heart. Although spironolactone is very effective in
patients that do not require dialysis, we do not know if spironolactone is effective in
dialysis patients. Our research will help determine if spironolactone reduces heart failure
and heart related deaths in dialysis patients.

The purpose of this study is to determine if spironolactone reduces death or hospitalization
for heart failure and is well tolerated in patients that require dialysis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03020303
Trial related presentations / publications
Quach K, Lvtvyn L, Baigent C, Bueti J, Garg AX, Hawley C, Haynes R, Manns B, Perkovic V, Rabbat CG, Wald R, Walsh M. The Safety and Efficacy of Mineralocorticoid Receptor Antagonists in Patients Who Require Dialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Oct;68(4):591-598. doi: 10.1053/j.ajkd.2016.04.011. Epub 2016 Jun 3.
Walsh M, Manns B, Garg AX, Bueti J, Rabbat C, Smyth A, Tyrwhitt J, Bosch J, Gao P, Devereaux PJ, Wald R. The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1602-8. doi: 10.2215/CJN.12371214. Epub 2015 Jul 2.
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03020303