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Spironolactone TO Prevent cardiovascular events in early stage Chronic Kidney Disease (CKD)

Spironolactone TO Prevent cardiovascular events in early stage Chronic Kidney Disease (CKD): A pilot trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80658312
Enrollment
500
Registered
2013-04-04
Start date
2013-06-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Stage Chronic Kidney Disease Urological and Genital Diseases Chronic kidney disease, stage 1

Interventions

Spironolactone 25mg once daily (OD) or Placebo for 40 weeks

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female, age over 18 years 2. Diagnosis of CKD stage 3

Exclusion criteria

Exclusion criteria: 1. Diabetes Mellitus 2. Terminal disease or felt otherwise unsuitable by their general practitioner 3. Chronic heart failure i.e. a clinical diagnosis or known ejection fraction = 180/110 mmHg 10. Systolic blood pressure = 70mg/mmol 14. Serum potassium >= 5 mEq/L on screening blood test 15. Concomittant co-trimoxazole medication 16. Concomittant angiotensin-converting enzyme inhibitor and angiotensin II receptor blocker medication 17. Pregnancy

Design outcomes

Primary

MeasureTime frame
Change in carotid-femoral pulse wave velocity measured at baseline and 40 weeks

Secondary

MeasureTime frame
1. Change in blood pressure measured at baseline and 40 weeks 2. Change in estimated Glomerular Filtration Rate (eGFR) measured at baseline and 40 weeks 3. Incidence of hyperkalaemia measured at baseline and 40 weeks 4. Incidence of hypotension (20mmHg systolic drop on standing) measured at baseline and 40 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026