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.

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