Multi-centre Randomized Controlled Trial of angiotensin converting enzyme inhibitor (ACEi) /angiotensin receptor blocker (ARB) - withdrawal in chronic kidney disease – STOP-ACEi-STUDY (SAS)

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Chronic kidney disease (CKD) affects 1 in 10 adults in the UK and describes progressive loss of function of the kidneys over a period of months or years regardless of the original kidney disease. CKD can have serious implications for those affected including a risk of CKD progressing to complete kidney failure so that the affected person requires replacement of kidney function by dialysis treatment or kidney transplantation. Kidney disease is expensive with a high proportion of the health-care budget spent on people with CKD; the cost of dialysis treatment alone is ~£30,000/year. Patient quality of life can be poor, with dialysis leading to early death. Treating high blood pressure (BP) is the most important intervention that can slow progression of CKD to total kidney failure. Some people with CKD gain additional protection from drugs called Angiotensin Converting Enzyme inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs). These drugs treat high BP but also slow CKD progression by changing the pressure in the kidney. This may also influence hormone pathways that contribute to the decline of kidney function. However recent research suggests that in some people with advanced CKD (stages 4 & 5) who are progressing to complete kidney failure and are receiving treatment with an ACEi and/ or ARB, stopping these drugs leads to stabilization and improvement of kidney function and decreases or delays the need for dialysis treatment. This indicates that in some patients the very tablets that are being used to protect the kidneys may be contributing to a harmful decline in their function by some currently unknown mechanism. To date, the research on this is observational and to confirm the association between stopping these drugs and stabilization of kidney function requires a study to compare the outcomes of a group of people who have had these drugs stopped with a group who continue on the drug. This is called a randomised controlled trial (RCT). In the STOP-ACEi trial we will randomly allocate suitable participants (by chance) to either continue or to stop their ACEi/ARB treatment and then to follow-up these participants for 3-years. This study is needed before this treatment strategy can be put into routine clinical practice. In addition we will look at other effects of stopping these drugs such as effects on heart attacks, strokes and participant quality of life.