BCTU Easter Closure: Birmingham Clinical Trials Unit, including the telephone randomisation service will be closed from 17:00, Thursday 2 April 2015 until 09:00, Thursday 9 April 2015. The online randomisation and data entry service will still be available over the Easter period.
STOP-ACEi is a national multi-centre randomised controlled trial of Angiotensin Converting Enzyme inhibitor (ACEi) / Angiotensin Receptor Blocker (ARB) withdrawal in advanced renal disease.
Full Title: Multi-centre Randomised Controlled Trial of Angiotensin Converting Enzyme inhibitor (ACEi) / Angiotensin Receptor Blocker (ARB) withdrawal in advanced renal disease
Short Title: The STOP-ACEi Trial
Aim of the study: To test the hypothesis that stopping treatment with ACEi, ARB or a combination of both, compared with continuing on these treatments, improves or stabilises renal function in patients with progressive stage 4 or 5 Chronic Kidney Disease (CKD).
Study design: Open-label randomised controlled trial (RCT).
Sample size: 410 patients will be recruited into the study (205 in each arm) over a 2 year period.
Study Duration: The accrual period is for 2 years and all patients will be followed up for 36 months. The end of trial will be 6 months after the last data capture. The total study duration is 6 years.
Timeframes: NIHR/MRC EME programme grant start date: 1st February 2014. Trial set up will take place in 6 months, recruitment will take 24 months, all patients will be followed up for 36 months and 6 months has been allocated for data analysis and report writing. We aim to recruit the first participant in April/May 2014.
Chief Investigator: Prof Sunil Bhandari
Trial Sponsor: Hull and East Yorkshire Hospitals NHS Trust. Ref.: R1578.
Funding: National Institute for Health Research and Medical Research Council Efficacy and Mechanism Evaluation programme (NIHR/MRC EME). Ref: 11/30/07.
EudraCT Number: 2013-003798-82
MHRA CTA: 21411/0242/001-0001 (12th December 2013).
Research Ethics Committee: Yorkshire and The Humber, Leeds East. Ref: 13/YH/0394. (29th January 2014).
NIHR CRN Study ID: 15908
IRAS project ID:138827