02294nas a2200289 4500000000100000008004100001260001700042100001700059700001700076700001800093700001800111700002500129700002300154700001800177700001900195700001900214700001700233700001800250700002100268700001800289700012100307245015400428300001200582490000700594520138900601022001401990 2017 d c1828370161111 aCoresh Josef1 aLevin Adeera1 aWalsh Michael1 aWheeler David1 aWinkelmayer Wolfgang1 aHerrington William1 aBaigent Colin1 aPerkovic Vlado1 aLandray Martin1 aPfeffer Marc1 aRossing Peter1 aWanner Christoph1 aMcMurray John1 aKDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants00aChallenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease-Improving Global Outcomes (KDIGO) Controversies Conference. a297-3050 v923 a

Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled "Challenges in the Conduct of Clinical Trials in Nephrology" to identify the key barriers to conducting trials in patients with kidney disease. The conference began with plenary talks focusing on the key areas of discussion that included appropriate trial design (covering identification and evaluation of kidney and nonkidney disease outcomes) and sensible trial execution (with particular emphasis on streamlining both design and conduct). Break out group discussions followed in which the key areas of agreement and remaining controversy were identified. Here we summarize the main findings from the conference and set out a range of potential solutions. If followed, these solutions could ensure future trials among people with kidney disease are sufficiently robust to provide reliable answers and are not constrained by inappropriate complexities in design or conduct.

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