@article{07d526b04e2b44d0882dca3e0f80fd2c,
title = "The Canadian ACE-inhibitor trial to improve renal outcomes and patient survival in kidney transplantation - Study design",
author = "Knoll, {Greg A.} and Marcelo Cantarovitch and Ed Cole and John Gill and Sita Gourishankar and Dave Holland and Bryce Kiberd and Norman Muirhead and Ramesh Prasad and Tibbles, {Lee Anne} and Darin Treleaven and Dean Fergusson",
note = "Funding Information: The trial is a randomized, prospective, double-blind, placebo-controlled, multicentre, parallel arm trial. The trial will recruit patients over a 2-year period and follow each participant for a minimum of 2 years. Following a screening visit to confirm eligibility, patients will have one randomization visit and study visits at 1 month, 2 months, 6 months, 12 months and then every 6 months until the trial is completed. In addition to these visits, the patients will have the serum creatinine measured every 3 months. The total trial duration will be 4 years. This study has been funded by a peer-reviewed grant from the Canadian Institutes of Health Research (grant # MCT-78844). The trial has been registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN-78129473). Funding Information: Abstract Background. In non-transplant patients with chronic kidney disease and proteinuria, inhibition of the renin– angiotensin system with an ACE-inhibitor or an angiotensin receptor blocker has been shown to delay the progression of renal disease. Observational studies in the kidney transplant population have produced conflicting results with some studies showing benefit and others no benefit of renin–angiotensin system blockade. Methods. This report describes the design and methodological issues of a randomized controlled trial evaluating the effect of ramipril in a renal transplant population. This study has been funded by a peer-reviewed grant from the Canadian Institutes of Health Research and is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN-78129473). Results. The study will randomize 528 kidney transplant patients (11 Canadian centers) with proteinuria and an estimated GFR between 20 and 55 ml/min/1.73 m2 to either ramipril (5 mg BID) or placebo. Patients, clinical staff and investigators will be blinded to treatment allocation. The primary outcome will be a composite measure incorporating doubling of serum creatinine, end stage renal disease or death. Principal secondary outcomes include: decline in GFR using a radioisotopic method, change in proteinuria, change in blood pressure, incidence of adverse events (e.g. hyperkalemia, anemia), incidence of cardiovascular events and health-related quality of life assessed by the Short Form-36 and the EuroQol-5D. Conclusions. Upon completion, this trial will provide clinically meaningful evidence about whether treatment with an ACE-inhibitor will reduce patient mortality and prolong allograft survival in renal transplant recipients.",
year = "2008",
month = jan,
doi = "10.1093/ndt/gfm574",
language = "English",
volume = "23",
pages = "354--358",
journal = "Nephrology Dialysis Transplantation",
issn = "0931-0509",
publisher = "Oxford University Press",
number = "1",
}