Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease

Conditions: chronic kidney disease
MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-000654-55-GB

Lead Sponsor: niversity of Birmingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Age over 18 years
2. Diagnosis of CKD Stage 3 (eGFR 30-59 ml/min/1.73m2) using the MDRD (Modification of Diet in Renal Disease) equation.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

•Diabetes Mellitus
•Terminal disease or felt otherwise unsuitable by their general practitioner (GP)
•Chronic heart failure i.e. a clinical diagnosis or known ejection fraction (EF) <55%
•Atrial fibrillation
•Alcohol or drug abuse
•Inability to comply with trial medication and follow-up
•Documented previous hyperkalaemia or intolerance of spironolactone
•Documented Addison’s disease and/or on fludrocortisone
•Severe hypertension: blood pressure = 180/110 mmHg
•Systolic blood pressure less than 120mmHg
•Recent acute kidney injury or hospital admission (within past 6 weeks)
•Chronic diarrhoea
•Pregnancy
•ACR>70 mg/mmol (will require specialist referral if not already made)
•Serum potassium = 5 mmol/L on screening blood test
•Concomitant co-trimoxazole medication
•Concomitant angiotensin-converting enzyme inhibitor AND angiotensin II receptor blocker medication