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

NCT03020303

CompletedPhase 3

Sponsor: Hamilton Health Sciences Corporation

Conditions: Endstage Renal Disease

Interventions: Spironolactone 25Mg Tablet, Placebo Oral Tablet

Countries: Australia, Brazil, Canada, China, Ecuador, India, Malaysia, New Zealand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

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

Locations (141)

Garran, Australian Capital Territory, Australia
Concord, New South Wales, Australia
Frenchs Forest, New South Wales, Australia
Wahroonga, New South Wales, Australia
Wahroonga, New South Wales, Australia
Birtinya, Queensland, Australia
Herston, Queensland, Australia
Woolloongabba, Queensland, Australia
Clayton, Victoria, Australia
Saint Albans, Victoria, Australia
Santa Efigênia, Belo Horizonte, Brazil
Rubião Júnior, Botucatu, Brazil
Boa Vista, Joinville, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Ubá, Minas Gerais, Brazil
Campina Grande do Sul, Paraná, Brazil
Curitiba, Paraná, Brazil
Bairro Santa Teresa, Porto Alegre, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Brusque, Santa Catarina, Brazil
Blumenau, South Carolina, Brazil
Santo André, São Paulo, Brazil
Votuporanga, São Paulo, Brazil
Bela Vista, Brazil
Ponta Grossa, Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Kamloops, British Colombia, Canada
Kelowna, British Colombia, Canada
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