Extrait

Background and study aims Chronic Kidney Disease (CKD) affects around 10% of the population. Cardiovascular disease (CVD) is a major cause of morbidity (the relative occurrence of disease) and death in CKD, although this is of a different phenotype (composition) from the general CVD population. Currently, few therapies have proved effective in modifying the increased CVD risk or the rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARAs) may offer cardio-protection and delay renal impairment in patients with the cardiovascular phenotype in CKD. The use of an aldosterone receptor blocker in CKD has therefore been increasingly advocated. The aim of the trial is to determine the effects of an ARA on renal and CVD outcomes. Who can participate? Six NIHR School for Primary Care Research departments will recruit approximately 300 GP practices which in turn will aim to recruit approximately 3022 men and women who meet the criteria for a diagnosis of CKD stage 3b or low stage 3a (ascertained from their last 2 blood tests); the participants also need to meet full trial inclusion criteria. What does the study involve? Participants will be seen over a period of 3 years. They will be randomly allocated (by a computer programme) to one of two groups of the trial, either a) to receive routine care only, or b) to receive the aldosterone receptor antagonist Spironolactone (25mg daily dose) on top of routine care. After their initial visit and random allocation to one of the two groups, the follow-up schedule of visits will be at weeks 1, 2, 4, 12, 26 and then at intervals of once every 13 weeks until the end of their participation at 156 weeks. The trial measurements will vary according to the schedule, but will consist of a combination of: - blood pressure measurement - blood tests - side-effect monitoring - questionnaires - drug monitoring diary card completion - home blood pressures diary card completion A subgroup of participants will take part in some additional procedures at intervals: - 24-hour ambulatory blood pressure measurements - pulse wave velocity and other arterial wall measurements What are the possible benefits and risks of participating? The group receiving Spironolactone potentially may derive protection against further kidney damage and heart disease. However, this will not be known until after trial completion. The group not receiving Spironolactone will receive no potential additional benefit on top of routine care, but do have the knowledge that their contribution to research helps towards the development of better treatments for people suffering from chronic kidney disease. The group not receiving trial medication will continue to receive routine care from their GP and therefore will be at no further risk by taking part in the trial. As will all medications, there are potential side-effects from taking Spironolactone, but it is a medication that has been used for various conditions for many years and is considered safe to take for people with no sensitivity to it. Participants are closely monitored during the trial for any side-effects. The main safety concern would be an increased level of potassium in the blood (previous research has shown approximately 2 in 100 people may develop high potassium), therefore frequent blood samples are taken in the early part of the trial to check the level. Where is the study run from? University of Oxford Primary Care Clinical Trials Unit (UK) When is the study starting and how long is it expected to run for? June 2013 to December 2021 Who is funding the study? The National Institute for Health Research School for Primary Care Research (UK) Who is the main contact? Dr Louise Jones [email protected]

Critère d'inclusion

• Topic: Primary Care Research Network for England; Disease: Chronic Kidney Disease

Liens

• ictrp
• isrctn