STOP-CKD version 1.0

• Research type

  Research Study

• Full title

  Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (CKD): A Pilot Trial

• IRAS ID

  96919

• Contact name

  Charles Ferro

• Sponsor organisation

  University of Birmingham

• Eudract number

  2012-000654-55

• ISRCTN Number

  N.A

• Research summary

  About 1 in 10 people are living with reduced kidney function because mild (early stage) chronic kidney disease (CKD) is common and kidney function reduces with age. Patients with CKD have reduced survival rate due to high rate of heart and blood vessels diseases. Even people with mild CKD have premature stiffening and reduced function of their heart and blood vessels. Our previous research of 112 people with early CKD from a specialist hospital kidney clinic showed that a 'water tablet' called spironolactone improves heart structure and function as well as reduced blood vessel stiffness. STOP-CKD study aims to confirm the findings in people with early CKD managed at general practices. The study will recruit 240 patients from 10 general practices, who have estimated kidney function between 30-59% on the blood test (mild CKD). Patients who are willing to participate in the study will be assigned to receive ??study tablets??, which are either spironolactone or placebo (??dummy tablet??) at random. Both patients and doctors will not know who is taking which tablets. Blood and urine test, blood pressure and blood vessel stiffness will be measured before starting the tablets. Blood vessel stiffness is measured by how fast the pulse travels from neck to groin using cuffs which detect pulse on both sites. Patients will be taking the tablets for 40 weeks, during which time; they will be followed-up and monitored regularly at their local general practices with blood test, blood pressure measurement and side effect questionnaire. After 40 weeks of receiving the tablets, repeat blood and urine test, blood pressure and blood vessel stiffness will be measured on the patients. After stopping the ??study tablets?? at 40 weeks, patients participating in the study will have repeat blood and urine tests, blood pressure and blood vessel stiffness measured at week 46.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  12/WM/0168

• Date of REC Opinion

  1 Aug 2012

• REC opinion

  Further Information Favourable Opinion