Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference

Colin Baigent, William Herrington, Josef Coresh, Martin Landray, Adeera Levin, Vlado Perkovic, Marc Pfeffer, Peter Rossing, Michael Walsh, Christoph Wanner, David Wheeler, Wolfgang Winkelmayer, John McMurray, Ali Abu-Alfa, Patrick Archdeacon, Geoffrey Block, Fergus Caskey, Alfred Cheung, Bruce Cooper, Jonathan CraigLaura Dember, Garabed Eknoyan, Ron Gansevoort, John Gill, Barbara Gillespie, Tom Greene, David Harris, Richard Haynes, Brenda Hemmelgarn, Charles Herzog, Thomas Hiemstra, Lesley Inker, Meg Jardine, Vivekanand Jha, Lixin Jiang, Kirsten Johansen, Reshma Kewalramani, Hiddo Lambers Heerspink, Martin Lefkowitz, Charmaine Lok, Fiona Loud, Romaldas Maciulaitis, Dugan Maddux, Franklin Maddux, Magdalena Madero, Segundo Mariz, Michael Mauer, Joseph Nally, Masaomi Nangaku, Ikechi Okpechi, Patrick Parfrey, Roberto Pecoits-Filho, Brian Pereira, Michael Rocco, Patrick Rossignol, Franz Schaefer, Francesca Tentori, Aliza Thompson, Marcello Tonelli, Allison Tong, Robert Toto, Katherine Tuttle, Thorsten Vetter, Angela Wang, Faiez Zannad

Research output: Contribution to journalArticlepeer-review

41 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)297-305
Number of pages9
JournalKidney International
Volume92
Issue number2
DOIs
Publication statusPublished - 2017

Keywords

  • kidney disease
  • randomized clinical trials
  • trial conduct
  • trial design

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