Multi-centre randomised controlled trial of Angiotensin Converting Enzyme inhibitor (ACEi) / Angiotensin Receptor Blocker (ARB) withdrawal in advanced renal disease
- Conditions
- Progressive, advanced (stage 4 or 5) chronic kidney disease (CKD). NB. There was not an appropriate therapeutic area in the drop down menu in E1-1. Have selected 'Male diseases of the urinary and reproductive systems', but this trial is for a disease of the male and female urinary system.MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2013-003798-82-GB
- Lead Sponsor
- Hull & East Yorkshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 410
•Aged =18 years (male or female);
•CKD stages 4 or 5 (eGFR <30mls/minute using the MDRD equation)and not on dialysis therapy;
•Progressive deterioration in renal function (fall in eGFR of >2ml/min/year over previous 12-24 months) as measured by linear regression analysis. A simple excel spread sheet for calculation of this will be provided to all sites. A minimum of 3 measurements of eGFR over the previous 12-24 months are required to identify a >2ml/min fall. Last eGFR must be within three months of randomisation.
•Treatment with either an ACEi or ARB or a combination of both for >6 months with at least 25% of the maximum recommended daily dose on the day of consent;
•Resting blood pressure (BP) =160/90 mmHg when measured in accordance with British Hypertension Society guidelines in clinic or recent home blood pressure readings within the previous month or a 24h ambulatory blood pressure measurement within in the last 3 months are acceptable.
•At least 3 months of specialist renal follow-up at the time of entry into the trial;
•Written, signed informed consent to the trial.
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 226
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 185
•Aged <18 years;
•Uncontrolled hypertension (>160/90mmHg) or requirement for 5 or more agents to control BP;
•Undergoing dialysis therapy;
•Any condition which, in the opinion of the investigator, makes the participant unsuitable for trial entry due to prognosis/terminal illness with a projected survival of less than 12 months;
•History of myocardial infarction or stroke in preceding 3 months;
•Participation in an interventional research study in preceding 6 weeks;
•Pregnancy, confirmed by positive pregnancy test or breastfeeding;
•Inability to provide informed consent (e.g. due to cognitive impairment);
•Immune mediated renal disease requiring disease specific treatment;
•Known drug or alcohol abuse;
•Inability to comply with the trial schedule and follow-up.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method