STOP-ACEi

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.

Christmas Closure 2014

Please note BCTU will be closed from 4pm on Tuesday 23rd December 2014 until 9am on Monday 5th January 2015.

Trial details

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.

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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).

ISRCTN:  ISRCTN62869767

NIHR CRN Study ID: 15908

IRAS project ID:138827