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NCT03020303CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2538 (actual)
First submitted
11 Jan 2017
Start date
7 Jul 2017
Primary completion date
14 Mar 2025
Lead sponsor
Hamilton Health Sciences Corporation
NCT number
NCT03020303

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 2538
  • From 7 Jul 2017 to the primary completion date, 14 Mar 2025
  • 141 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).
  • Scheduled living related donor renal transplant
  • Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.

Other illness

  • Known sensitivity or allergy to spironolactone

Lab values

  • 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

Other

  • Current or planned pregnancy or breastfeeding
  • Life expectancy \< 6 months in the opinion of a treating nephrologist.
  • Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (141)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sunshine Coast University Hospital
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BirtinyaAustraliaUnknown status
Monash Health
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ClaytonAustraliaUnknown status
Concord Repatriation General Hospital
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ConcordAustraliaUnknown status
Northern Beaches Hospital
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Frenchs ForestAustraliaUnknown status
Canberra Hospital
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GarranAustraliaUnknown status
Royal Brisbane Women&#39;s Hospital
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HerstonAustraliaUnknown status
Western Health - Sunshine Hospital
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Saint AlbansAustraliaUnknown status
Royal North Shore Hospital
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WahroongaAustraliaUnknown status
Sydney Adventist Hospital
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WahroongaAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA
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Bairro Santa TeresaBrazilUnknown status
Hospital Alemao Oswaldo Cruz
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Bela VistaBrazilUnknown status
Felicio Rocho Foundation - Hospital Felicio Rocho
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Belo HorizonteBrazilUnknown status
Fundação Hospitalar São Francisco de Assis
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Belo HorizonteBrazilUnknown status
PROCARDIO Clinica Cardiologica
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BlumenauBrazilUnknown status
Fundacao Pro-Rim
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Boa VistaBrazilUnknown status
Hospital Arquidiocesano Consul Carlos Reneaux
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BrusqueBrazilUnknown status
Sociedade Hospitalar Angelina Caron
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Campina Grande do SulBrazilUnknown status
Instituto Pro Renal Brazil
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CuritibaBrazilUnknown status
Santa Casa de Misericórdia de Ponta Grossa
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Ponta GrossaBrazilUnknown status
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Medical School of Botucatu of the Paulista State University - UNESP
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Rubião JúniorBrazilUnknown status
Santa Casa de Misericordia de Belo Horizonte
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Santa EfigêniaBrazilUnknown status
Praxis Pesquisa Medica S/S
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Santo AndréBrazilUnknown status
Serviço Ubaense de Nefrologia Ltda
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UbáBrazilUnknown status
Santa Casa de Misericórdia de Votuporanga
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VotuporangaBrazilUnknown status
Foothills Hospital
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CalgaryCanadaUnknown status
University of Alberta
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EdmontonCanadaUnknown status
Health Sciences North Research Institute
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Greater SudburyCanadaUnknown status
Queen Elizabeth II Health Science Centre
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HalifaxCanadaUnknown status
St. Joseph's Healthcare
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HamiltonCanadaUnknown status
Royal Inland Hospital
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KamloopsCanadaUnknown status
Kelowna General Hospital
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KelownaCanadaUnknown status
Queens University at Kingston General Hospital, Division of Nephrology
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KingstonCanadaUnknown status
Victoria Hospital
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LondonCanadaUnknown status
The Sir Mortimer B. Davis Jewish General Hospital
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MontrealCanadaUnknown status
Centre Hospitalier de l&#39;Universite de Montreal (CHUM)
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MontrealCanadaUnknown status
CIUSSS Hopital Maisonneuve- Rosemont
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MontrealCanadaUnknown status
Hopital Du Sacre Coeur de Montreal
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MontrealCanadaUnknown status
Ottawa Hospital Research Institute
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OttawaCanadaUnknown status
Penticton Regional Hospital
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PentictonCanadaUnknown status
CHU de Quebec - L'Hôtel-Dieu de Québec
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QuébecCanadaUnknown status
Cape Breton Regional Hospital
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SydneyCanadaUnknown status
Humber River Health
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TorontoCanadaUnknown status
St. Josephs, Toronto
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TorontoCanadaUnknown status
St. Michael's Hospital
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TorontoCanadaUnknown status
St Pauls Hospital
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VancouverCanadaUnknown status
The First Affiliated Hospital of Baotou Medical College
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BaotouChinaUnknown status
Beijing Tongren Hospital, Capital Medical University
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BeijingChinaUnknown status
Emergency General Hospital
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Beijing Miyun District Hospital
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BeijingChinaUnknown status
Peking University Peoples Hospital
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BeijingChinaUnknown status
Faw General Hospital of Jilin Province
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ChangchunChinaUnknown status
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
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EnshiChinaUnknown status
Huai'an First Peoples Hospital
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Huai'anChinaUnknown status
The First Hospital of Kunming
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KunmingChinaUnknown status
Gansu Baoshihua Hospital
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LanzhouChinaUnknown status
Yichuan County Traditional Chinese Medicine Hospital
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LuoyangChinaUnknown status
Shanghai Tongji Hospital
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ShanghaiChinaUnknown status
Shanxi Provincial Peoples Hospital
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ShanxiChinaUnknown status
Shuyang County Hospital of Traditional Chinese Medicine
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SuqianChinaUnknown status
Sihong County Fenjinting Hospital
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SuqianChinaUnknown status
Tianjin Third Central Hospital
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TianjinChinaUnknown status
Tianjin Fifth Central Hospital
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TianjinChinaUnknown status
Tongiao City Hospital
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TongliaoChinaUnknown status
Xinxiang First Peoples Hospital
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XinxiangChinaUnknown status
General Hospital of Xuzhou Mining Group
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XuzhouChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
Peoples Hospital of Yuxi City
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YuxiChinaUnknown status
Peoples Hospital of Zhongwei
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ZhongweiChinaUnknown status
Clinefnorte CIA Ltda
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QuitoEcuadorUnknown status
Nefromedic SA
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QuitoEcuadorUnknown status
Aberdeen Royal Infirmary
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AberdeenUnited KingdomUnknown status
Belfast City Hospital
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BelfastUnited KingdomUnknown status
Birmingham Hospitals
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BirminghamUnited KingdomUnknown status
Southmead Hospital
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BristolUnited KingdomUnknown status
East Kent Canterbury Hospital
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CanterburyUnited KingdomUnknown status
University Hospital of Whales Health Park
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CardiffUnited KingdomUnknown status
Epsom St. Helier
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CarshaltonUnited KingdomUnknown status
Royal Derby Hospital
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DerbyUnited KingdomUnknown status
Ninewells Hospital
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DundeeUnited KingdomUnknown status
Ulster Hospital
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DundonaldUnited KingdomUnknown status
Queen Elizabeth University Hospital
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GlasgowUnited KingdomUnknown status
Churchill Hospital
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HeadingtonUnited KingdomUnknown status
Leicester General Hospital
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LeicesterUnited KingdomUnknown status
Liverpool University Hospitals
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LiverpoolUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
The Royal London Hospital
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LondonUnited KingdomUnknown status
South Tees James Cook Hospital
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MiddlesbroughUnited KingdomUnknown status
Daisy Hill Hospital
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NewryUnited KingdomUnknown status
City Hospital
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NottinghamUnited KingdomUnknown status
Salford Royal Hospital
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SalfordUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Narayana Hrudayalaya Limited
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BangaloreIndiaUnknown status
Fortis Hospitals
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BengaluruIndiaUnknown status
Vijaya Hospital
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ChennaiIndiaUnknown status
Apollo Hospitals
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ChennaiIndiaUnknown status
AIMS Hospital Mumbai
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DombivaliIndiaUnknown status
Osmania General Hospital
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HyderabadIndiaUnknown status
Nizams Institute of Medical Sciences
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HyderabadIndiaUnknown status
AsterMedCity
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KochiIndiaUnknown status
Caritas Hospital
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KottayamIndiaUnknown status
Government Rajaji Hospital, Madurai
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MaduraiIndiaUnknown status
Father Muller Medical College
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MangaloreIndiaUnknown status
K S Hegde Medical Academy
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MangaluruIndiaUnknown status
Ashirwad Hospital Mumbai
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MumbaiIndiaUnknown status
National Health and Education Society
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MumbaiIndiaUnknown status
Seven Star Hospital
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NagpurIndiaUnknown status
Dhadiwal Hospital
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NashikIndiaUnknown status
Madras Medical College Chennai
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Park TownIndiaUnknown status
Aditya Birla Hospital
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PuneIndiaUnknown status
ACE Hospital Une
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PuneIndiaUnknown status
Nanjappa Hospitals Shimoga
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ShimogaIndiaUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Sultanah Aminah Johor Bahru
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Johor BahruMalaysiaUnknown status
Hospital Kajang
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KajangMalaysiaUnknown status
Hospital Tengku Ampuan Rahimah Klang
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KlangMalaysiaUnknown status
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaUnknown status
University Malaya Medical Centre (UMMC)
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Kuala LumpurMalaysiaUnknown status
Hospital Sultanah Nur Zahirah Kuala Terengganu
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Kuala TerengganuMalaysiaUnknown status
Hospital Tengku Ampuan Afzan, Kuantan
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KuantanMalaysiaUnknown status
Hospital Pakar Sultanah Fatimah
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Muar townMalaysiaUnknown status
Hospital Tuanku Jaafar Seremban
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SerembanMalaysiaUnknown status
Hospital Ampang
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SetapakMalaysiaUnknown status
Hospital Taiping
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TaipingMalaysiaUnknown status
Dunedin Hospital
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DunedinNew ZealandUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Hawkes Bay Hospital
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HastingsNew ZealandUnknown status
Palmerston North Hospital
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Palmerston NorthNew ZealandUnknown status
North Shore Hospital
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TakapunaNew ZealandUnknown status
Whangarei Hospital
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WhangareiNew ZealandUnknown status
Philippines General Hospital
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ErmitaPhilippinesUnknown status
National Kidney and Transplant Institute
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Quezon CityPhilippinesUnknown status
Canimel Center
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MeloUruguayUnknown status
SEDIC Center
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MontevideoUruguayUnknown status
Cedina Center
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MontevideoUruguayUnknown status
Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP)
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MontevideoUruguayUnknown status
Hacettepe University Hospitals Hemodialysis Center
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AnkaraTurkey (Türkiye)Unknown status
Osmangazi University
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EskişehirTurkey (Türkiye)Unknown status
Memorial Service Hospital
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.