AzTrials
AzTrials

Endstage Renal DiseasePhase 3ACHIEVENCT03020303

Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

A Phase 3 study testing Spironolactone 25Mg Tablet in people with Endstage Renal Disease, run by Hamilton Health Sciences Corporation at 141 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endstage Renal Disease
What is being tested?
Spironolactone 25Mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,538 participants
Where
141 sitesin 12 countries
Study dates
7 Jul 2017to 14 Mar 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age
  • ≥45 years or
  • ≥18 with a history of diabetes
  • On dialysis ≥ 90 days
  • On either
  • Hemodialysis prescribed at least 2 treatments per week or
  • Peritoneal dialysis prescribed with at least 1 exchange daily
  • Provides informed consent

Who cannot join

  • Hyperkalemia
  • Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or
  • Serum potassium >6.0 mmol/L during active run-in
  • Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).
  • Known sensitivity or allergy to spironolactone
  • Current or planned pregnancy or breastfeeding
Show all 10Show fewer
  • Scheduled living related donor renal transplant
  • Life expectancy < 6 months in the opinion of a treating nephrologist.
  • Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.
  • Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated

Trial locations and contacts

141 sites in 12 countries.

141 sites in 12 countries

China24 sites

  • The First Affiliated Hospital of Baotou Medical College

    Baotou

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality

  • Beijing Miyun District Hospital

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • Emergency General Hospital

    Beijing

  • Faw General Hospital of Jilin Province

    Changchun

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

    Enshi

  • Huai'an First Peoples Hospital

    Huai'an

  • The First Hospital of Kunming

    Kunming

  • Gansu Baoshihua Hospital

    Lanzhou

  • Yichuan County Traditional Chinese Medicine Hospital

    Luoyang

  • Shanghai Tongji Hospital

    Shanghai

  • Shanxi Provincial Peoples Hospital

    Shanxi

  • Shuyang County Hospital of Traditional Chinese Medicine

    Suqian

  • Sihong County Fenjinting Hospital

    Suqian

  • Tianjin Fifth Central Hospital

    Tianjin

  • Tianjin Third Central Hospital

    Tianjin

  • Tongiao City Hospital

    Tongliao

  • Xinxiang First Peoples Hospital

    Xinxiang

  • General Hospital of Xuzhou Mining Group

    Xuzhou

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

  • Peoples Hospital of Yuxi City

    Yuxi

  • Peoples Hospital of Zhongwei

    Zhongwei

Other trials in China

Canada21 sites

  • Foothills Hospital

    Calgary, Alberta, T2N 2T9

  • University of Alberta

    Edmonton, Alberta, T6G 2G3

  • Health Sciences North Research Institute

    Greater Sudbury, Ontario, P3E 5J1

  • Queen Elizabeth II Health Science Centre

    Halifax, Nova Scotia, B3H 1V7

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • Royal Inland Hospital

    Kamloops, British Colombia, V2C 2T1

  • Kelowna General Hospital

    Kelowna, British Colombia, V1Y 1T2

  • Queens University at Kingston General Hospital, Division of Nephrology

    Kingston, Ontario

  • Victoria Hospital

    London, Ontario, N6A 5W9

  • CIUSSS Hopital Maisonneuve- Rosemont

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l&#39;Universite de Montreal (CHUM)

    Montreal, Quebec, H2W 1T8

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • The Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9

  • Penticton Regional Hospital

    Penticton, British Columbia

  • CHU de Quebec L'Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Cape Breton Regional Hospital

    Sydney, Nova Scotia

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • St. Josephs, Toronto

    Toronto, Ontario, M6R 1B5

  • Humber River Health

    Toronto, Ontario

  • St. Pauls Hospital

    Vancouver, British Colombia, V6Z 1Y6

Other trials in Canada

United Kingdom21 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB23 2ZN

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Birmingham Hospitals

    Birmingham

  • Southmead Hospital

    Bristol, Bristol, BS10 5NB

  • East Kent Canterbury Hospital

    Canterbury, Kent, CT1 3NG

  • University Hospital of Whales Health Park

    Cardiff, Cardiff, CF14 4XW

  • Epsom St. Helier

    Carshalton

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Ulster Hospital

    Dundonald, Belfast, BT16 1RH

  • Queen Elizabeth University Hospital

    Glasgow, Glasgow, G51 4TF

  • Churchill Hospital

    Headington, Oxford, OX3 7LE

  • Leicester General Hospital

    Leicester

  • Liverpool University Hospitals

    Liverpool

  • The Royal London Hospital

    London, London, E1 2ES

  • Kings College Hospital

    London, London, SE5 9RS

  • South Tees James Cook Hospital

    Middlesbrough

  • Daisy Hill Hospital

    Newry, Down, BT35 8DR

  • City Hospital

    Nottingham, Nottingham, NG5 1PB

  • Salford Royal Hospital

    Salford, Salford, M6 8HD

  • Royal Stoke University Hospital

    Stoke-on-Trent

Other trials in United Kingdom

India20 sites

  • Narayana Hrudayalaya Limited

    Bangalore, Karnataka, 560099

  • Fortis Hospitals

    Bengaluru, Karnataka, 560076

  • Vijaya Hospital

    Chennai, Tamil Nadu, 600026

  • Apollo Hospitals

    Chennai, Tamil Nadu, 600081

  • AIMS Hospital Mumbai

    Dombivali, Maharashtra, 421203

  • Nizams Institute of Medical Sciences

    Hyderabad, Telangana, 500082

  • Osmania General Hospital

    Hyderabad, Telegana, 500012

  • AsterMedCity

    Kochi, Kerala, 682027

  • Caritas Hospital

    Kottayam, Kerala, 686630

  • Government Rajaji Hospital, Madurai

    Madurai

  • Father Muller Medical College

    Mangalore

  • K S Hegde Medical Academy

    Mangaluru, Karnataka, 575018

  • National Health and Education Society

    Mumbai, Maharashtra, 400016

  • Ashirwad Hospital Mumbai

    Mumbai, Maharashtra, 421004

  • Seven Star Hospital

    Nagpur

  • Dhadiwal Hospital

    Nashik, Maharashtra, 422002

  • Madras Medical College Chennai

    Park Town, Chennai, 600003

  • ACE Hospital Une

    Pune, Maharashtra, 411004

  • Aditya Birla Hospital

    Pune, Maharashtra, 411033

  • Nanjappa Hospitals Shimoga

    Shimoga, Karnataka, 577201

Other trials in India

Brazil16 sites

  • Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA

    Bairro Santa Teresa, Porto Alegre, 90020090

  • Hospital Alemao Oswaldo Cruz

    Bela Vista

  • Felicio Rocho Foundation - Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais, 30110934

  • Fundacao Hospitalar Sao Francisco de Assis

    Belo Horizonte, Minas Gerais, 31110580

  • PROCARDIO Clinica Cardiologica

    Blumenau, South Carolina, 89010500

  • Fundacao Pro-Rim

    Boa Vista, Joinville, 89227680

  • Hospital Arquidiocesano Consul Carlos Reneaux

    Brusque, Santa Catarina, 8835404

  • Sociedade Hospitalar Angelina Caron

    Campina Grande do Sul, Paraná, 83430000

  • Instituto Pro Renal Brazil

    Curitiba, Paraná, 80440-020

  • Santa Casa de Misericordia de Ponta Grossa

    Ponta Grossa

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Medical School of Botucatu of the Paulista State University - UNESP

    Rubião Júnior, Botucatu, 18618-687

  • Santa Casa de Misericordia de Belo Horizonte

    Santa Efigênia, Belo Horizonte, 30150221

  • Praxis Pesquisa Medica S/S

    Santo André, São Paulo, 09090 790

  • Servico Ubaense de Nefrologia Ltda

    Ubá, Minas Gerais, 36500008

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo, 15500003

Other trials in Brazil

Malaysia12 sites

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

  • Hospital Sultanah Aminah, Johor Bahru

    Johor Bahru, Johor, 80100

  • Hospital Kajang

    Kajang, Selangor, 43000

  • Hospital Tengku Ampuan Rahimah Klang

    Klang, Selangor, 41200

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 42896

  • University Malaya Medical Centre (UMMC)

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Sultanah Nur Zahirah Kuala Terengganu

    Kuala Terengganu, Kuala Terengganu, 33158

  • Hospital Tengku Ampuan Afzan, Kuantan

    Kuantan, 29142

  • Hospital Pakar Sultanah Fatimah

    Muar town, Johor

  • Hospital Tuanku Jaafar, Seremban

    Seremban, 25167

  • Hospital Ampang

    Setapak, 53200

  • Hospital Taiping

    Taiping, Perak, 34000

Other trials in Malaysia

Australia10 sites

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Monash Health

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales, 2086

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Royal Brisbane Women&#39;s Hospital

    Herston, Queensland, 4029

  • Western Health - Sunshine Hospital

    Saint Albans, Victoria, 3021

  • Royal North Shore Hospital

    Wahroonga, New South Wales, 2076

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

New Zealand6 sites

  • Dunedin Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

  • Hawkes Bay Hospital

    Hastings, 4120

  • Palmerston North Hospital

    Palmerston North, 4442

  • North Shore Hospital

    Takapuna, Auckland, 0620

  • Whangarei Hospital

    Whangarei, 0148

Other trials in New Zealand

Uruguay4 sites

  • Canimel Center

    Melo, Departamento de Cerro Largo

  • SEDIC Center

    Montevideo, Montevideo Department, 11800

  • Cedina Center

    Montevideo

  • Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP)

    Montevideo

Other trials in Uruguay

Turkey (Türkiye)3 sites

  • Hacettepe University Hospitals Hemodialysis Center

    Ankara

  • Osmangazi University

    Eskişehir

  • Memorial Service Hospital

    Istanbul

Other trials in Turkey (Türkiye)

Ecuador2 sites

  • Clinefnorte CIA Ltda

    Quito, Pichincha, 170303

  • Nefromedic SA

    Quito, Pichincha, 170601

Other trials in Ecuador

Philippines2 sites

  • Philippines General Hospital

    Ermita, Manila, 1000

  • National Kidney and Transplant Institute

    Quezon City, Manila, 1101

Other trials in Philippines

About this study

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.

Read the detailed description

Globally, over 2 million people receive dialysis for end-stage renal disease (ESRD) and 650,000 new patients start dialysis each year. Furthermore, the number of patients receiving dialysis is increasing as access to dialysis in the developing world improves and the prevalence of diabetes and vascular disease rises. Despite technical advances in dialysis, the outcomes for patients with ESRD are poor. Patients have frequent hospitalizations, poor health related quality of life and strikingly, high mortality rates.

The most common cause of death in patients receiving dialysis is cardiovascular disease, accounting for >40% of all deaths. Observational studies suggest a causal pathway to cardiovascular death that includes progressive ventricular hypertrophy and dilatation as well as accelerated atherosclerosis. These changes result in myocardial ischemia and cardiac fibrosis that, in turn, lead to heart failure, arrhythmias and cardiac arrest. Strongly implicated in this pathophysiology is aldosterone. Mineralocorticoid receptor antagonists (MRAs) in non-ESRD patients, prevent cardiovascular deaths and small randomized controlled trials of MRAs in ESRD suggests they may reduce death and may be safe.

Spironolactone is the most commonly used MRA worldwide. We will conduct a multicentre randomized controlled trial (RCT) to determine if spironolactone reduces cardiac mortality and hospitalizations for heart failure in patients treated with dialysis. This trial is called the Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease (ACHIEVE).

Being tested
Spironolactone 25Mg Tablet, Placebo Oral Tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spironolactone 25Mg TabletDrug

    Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.

  • Placebo Oral TabletDrug

    Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.

Study groups in NCT03020303
Study groupRoleWhat they receive
Placebo Oral TabletPlacebo comparatorA tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance
Receives: Drug: Placebo Oral Tablet
Spironolactone 25 MG TabletActive comparator25 mg of active spironolactone in tablet form
Receives: Drug: Spironolactone 25Mg Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CV Death or Hospitalization for Heart Failure

    Measured: up to 5 years

Secondary outcomes (5)

  1. Cause specific death

    Measured: up to 5 years

  2. Hospitalization for Heart Failure

    Measured: up to 5 years

  3. All-cause death

    Measured: up to 5 years

  4. All-cause Hospitalization

    Measured: up to 5 years

  5. Hospitalization for hyperkalemia

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study start7 Jul 2017
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03020303
Sponsor's protocol ID
ACHIEVE Trial
Acronym
ACHIEVE
Status last verified
Mar 2025
First submitted
11 Jan 2017
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: N/A - no plan to make IPD available to other researchers

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.

    PubMed 27265777

  • 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.

    PubMed 26138259

  • Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Reis G, Xavier D, Liu WJ, Zuo L, Wang AY, Felix C, Sola L, Arici M, Villanueva R, Jha V, Precoma D, Rabbat CG, Alavudeen SS, Faruqui AR, Lopez-Flecher M, Pyne L, Wald R, Yuan F, Balasubramanian K, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial. Lancet. 2025 Aug 16;406(10504):695-704. doi: 10.1016/S0140-6736(25)01198-5.

    PubMed 40818850

  • Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Sola L, Reis G, Xavier D, Villanueva R, Liu WJ, Felix C, Zuo L, Arici M, Jha V, Wald R, Wang AY, Faruqui AR, Yuan F, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. The Aldosterone Blockade for Health Improvement Evaluation in End-Stage Renal Disease (ACHIEVE) Trial: Rationale and Clinical Research Protocol. Can J Kidney Health Dis. 2025 Jun 3;12:20543581251348187. doi: 10.1177/20543581251348187. eCollection 2025.

    PubMed 40470466

  • Huang B, McDowell G, Rao A, Lip GYH. Mineralocorticoid receptor antagonist for chronic kidney disease, risk or benefit? J Hypertens. 2024 Mar 1;42(3):396-398. doi: 10.1097/HJH.0000000000003643. Epub 2024 Feb 1. No abstract available.

    PubMed 38289999

  • Soomro QH, Charytan DM. Mineralocorticoid Receptor Antagonists and Cardiovascular Health with Kidney Failure. Clin J Am Soc Nephrol. 2021 Jun;16(6):843-845. doi: 10.2215/CJN.04460421. No abstract available.

    PubMed 34117077

  • Collister D, Mbuagbaw L, Guyatt G, Devereaux PJ, Tennankore KK, Reis G, Sola L, Xavier D, Jha V, Gallagher M, Dans AL, Liu W, de Zoysa J, Felix C, Mark PB, Li Z, Tyrwhitt J, Wilkinson J, Sheridan P, Yuan F, Walsh M; ACHIEVE investigators. Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial. Contemp Clin Trials. 2021 Aug;107:106466. doi: 10.1016/j.cct.2021.106466. Epub 2021 Jun 5.

    PubMed 34098039

  • Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

    PubMed 33586138

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Spironolactone 25Mg Tablet in people with Endstage Renal Disease, run by Hamilton Health Sciences Corporation at 141 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in China, Canada, United Kingdom, India, Brazil and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CV Death or Hospitalization for Heart Failure (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03020303, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in