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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN80658312
• Date of registration: 04/04/2013
• Prospective Registration: Yes
• Primary sponsor: University of Birmingham (UK)
• Public title: Spironolactone TO Prevent cardiovascular events in early stage Chronic Kidney Disease (CKD)
• Scientific title: Spironolactone TO Prevent cardiovascular events in early stage Chronic Kidney Disease (CKD): A pilot trial
• Date of first enrolment: 01/06/2013
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN80658312
• Study type: Interventional
• Study design: Randomised double-blinded placebo-controlled interventional trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Odette Chagoury

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male and female, age over 18 years
2. Diagnosis of CKD stage 3
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 <55%
4. Atrial fibrillation
5. Alcohol or drug abuse
6. Inability to comply with trial medication and follow-up
7. Documented previous hyperkalaemia or intolerance of spironolactone
8. Documented Addisonian crisis and/or on fludrocortisone
9. Severe hypertension: blood pressure >= 180/110 mmHg
10. Systolic blood pressure < 120mmHg
11. Recent acute kidney injury or hospital admission (within past 6 weeks)
12. Chronic diarrhoea
13. Albumin:creatinine ratio (ACR) >= 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

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 (<100mmHg or >20mmHg systolic drop on standing) measured at baseline and 40 weeks

Secondary ID(s)

13983

Source(s) of Monetary Support

NIHR (UK) - Research for Patient Benefit; Grant Codes: PB-PG-0110-21226