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.
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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).
Study Duration: The trial closed to recruitment in June 2018 after reaching the required sample size. All patients in the trial will be followed up for 36 months.
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 University Teaching 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
STOP-ACEi Protocol v3.0 (14th May 2014)
STOP-ACEi Online Data Entry
Contact the STOP-ACEi trial team