Literature DB >> 15023136

Biomarkers and surrogate endpoints in renal transplantation: present status and considerations for clinical trial design.

Peter A Lachenbruch1, Amy S Rosenberg, Ezio Bonvini, Marc W Cavaillé-Coll, Robert B Colvin.   

Abstract

Of major importance in clinical trials is the ability to predict individual patient outcome or endpoints using biomarkers, also known as variables or predictors, in as safe, efficient, and accurate a manner as possible. This review addresses the concepts and possible strategies for use of predictor and surrogate biomarkers in the design of clinical trials in renal transplantation. The statistical concepts apply equally well to other organ grafts.

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Year:  2004        PMID： 15023136     DOI： 10.1111/j.1600-6143.2004.00386.x

Source DB:  PubMed          Journal:  Am J Transplant        ISSN： 1600-6135            Impact factor:   8.086


  13 in total

1.  Low-density array PCR analysis of reperfusion biopsies: an adjunct to histological analysis.

Authors:  Paolo Cravedi; Umberto Maggiore; Roslyn B Mannon
Journal:  Nephrol Dial Transplant       Date:  2010-05-26       Impact factor: 5.992

Review 2.  Tacrolimus versus ciclosporin as primary immunosuppression for kidney transplant recipients: meta-analysis and meta-regression of randomised trial data.

Authors:  Angela C Webster; Rebecca C Woodroffe; Rod S Taylor; Jeremy R Chapman; Jonathan C Craig
Journal:  BMJ       Date:  2005-09-12

3.  Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops.

Authors:  Allison Tong; John Gill; Klemens Budde; Lorna Marson; Peter P Reese; David Rosenbloom; Lionel Rostaing; Germaine Wong; Michelle A Josephson; Timothy L Pruett; Anthony N Warrens; Jonathan C Craig; Benedicte Sautenet; Nicole Evangelidis; Angelique F Ralph; Camilla S Hanson; Jenny I Shen; Kirsten Howard; Klemens Meyer; Ronald D Perrone; Daniel E Weiner; Samuel Fung; Maggie K M Ma; Caren Rose; Jessica Ryan; Ling-Xin Chen; Martin Howell; Nicholas Larkins; Siah Kim; Sobhana Thangaraju; Angela Ju; Jeremy R Chapman
Journal:  Transplantation       Date:  2017-08       Impact factor: 4.939

Review 4.  Biomarkers for kidney transplant rejection.

Authors:  Denise J Lo; Bruce Kaplan; Allan D Kirk
Journal:  Nat Rev Nephrol       Date:  2014-01-21       Impact factor: 28.314

5.  Probabilistic (Bayesian) modeling of gene expression in transplant glomerulopathy.

Authors:  Eric A Elster; Jason S Hawksworth; Orlena Cheng; David B Leeser; Michael Ring; Douglas K Tadaki; David E Kleiner; John S Eberhardt; Trevor S Brown; Roslyn B Mannon
Journal:  J Mol Diagn       Date:  2010-08-05       Impact factor: 5.568

6.  Biomarkers for early and late stage chronic allograft nephropathy by proteogenomic profiling of peripheral blood.

Authors:  Sunil M Kurian; Raymond Heilman; Tony S Mondala; Aleksey Nakorchevsky; Johannes A Hewel; Daniel Campbell; Elizabeth H Robison; Lin Wang; Wen Lin; Lillian Gaber; Kim Solez; Hamid Shidban; Robert Mendez; Randolph L Schaffer; Jonathan S Fisher; Stuart M Flechner; Steve R Head; Steve Horvath; John R Yates; Christopher L Marsh; Daniel R Salomon
Journal:  PLoS One       Date:  2009-07-10       Impact factor: 3.240

7.  High urinary excretion of kidney injury molecule-1 is an independent predictor of graft loss in renal transplant recipients.

Authors:  Mirjan M van Timmeren; Vishal S Vaidya; Rutger M van Ree; Leendert H Oterdoom; Aiko P J de Vries; Reinold O B Gans; Harry van Goor; Coen A Stegeman; Joseph V Bonventre; Stephan J L Bakker
Journal:  Transplantation       Date:  2007-12-27       Impact factor: 4.939

8.  Standardized Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD): Study Protocol for Establishing a Core Outcome Set in PD.

Authors:  Karine E Manera; Allison Tong; Jonathan C Craig; Edwina A Brown; Gillian Brunier; Jie Dong; Tony Dunning; Rajnish Mehrotra; Sarala Naicker; Roberto Pecoits-Filho; Jeffrey Perl; Angela Y Wang; Martin Wilkie; Martin Howell; Benedicte Sautenet; Nicole Evangelidis; Jenny I Shen; David W Johnson
Journal:  Perit Dial Int       Date:  2017-08-01       Impact factor: 1.756

9.  Efficacy and safety of immunosuppressive drugs approved in EU through the centralised procedure.

Authors:  Vittorio Bertele'; Carmela Buonocore; Francesca Michelacci; Maria Vitocolonna; Silvio Garattini
Journal:  Eur J Clin Pharmacol       Date:  2007-05-08       Impact factor: 3.064

Review 10.  Safety and Efficacy Endpoints for Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients.

Authors:  J R Bank; T J Rabelink; J W de Fijter; M E J Reinders
Journal:  J Immunol Res       Date:  2015-07-15       Impact factor: 4.818
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