title: PREventing Delayed Graft Function by Driving Immunosuppressive InduCtion Treatment (PREDICT-DGF): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  In kidney transplantation, the use of Anti-Thymocyte Globulins (ATG) as induction therapy has been described as a possible treatment for reducing the prevalence of Delayed Graft Function (DGF). ATG possesses pharmaceutical proprieties that could help control the lesions caused by ischemia reperfusion injury. However, other studies have questioned this potential protective effect. We hypothesized that the benefits related to ATG for reducing DGF prevalence may be higher and more consistently recognized if only patients with high DGF risk are considered. We recently proposed a scoring system entitled DGFS (Delayed Graft Function Score) for such stratification of kidney transplant recipients according to their risk of DGF. Using the DGFS calculation, we aim to determine whether a short course of ATG can decrease the incidence of DGF in comparison with Basiliximab in kidney transplant recipients with low immunological risk but high DGF risk.
  
  
  METHODS
  We conduct a phase IV, open label, randomized, multicentric and prospective study, to compare ATG in parallel with a control group treated by Basiliximab. The 1:1 randomized allocation of patients between groups is stratified on the clinical center, and on the hypothermic machine-perfusion device. We aimed to include a total of 384 patients to achieve a statistical power at 0.80. The study was initiated at the Nantes University hospital in July 2014, with data collection continuing until April 2018, and publication of the results proposed for 2019.
  
  
  CONCLUSIONS
  The main expected benefits of this study are i) the reduction of unjustified ATG over-prescriptions associated with serious adverse events, ii) the reduction of chance losses related to ATG under-prescription, iii) the decrease in the incidence of DGF which was described as a risk factor of graft failure and patient death, and iv) the reduction in hospitalization duration and number of post transplantation dialysis sessions, both being associated with reduced medical costs. In conclusion, the current study is innovative by proposing a more efficient and personalized induction therapy.
  
  
  BACKGROUND
  The study was registered in the Clinical Trials Registry (# NCT02056938, February 5, 2014), and in the European Clinical Trials Database (EudraCT #2014-000332-42, January 30, 2014).
authors.affiliation: ITUN and Inserm U1064, Nantes University, 30 Boulevard Jean Monnet, Nantes, 44035, France. Marion.CHAPAL@chu-nantes.fr.
authors.forename: Marion
authors.initials: M
authors.lastname: Chapal
authors.affiliation: ITUN and Inserm U1064, Nantes University, 30 Boulevard Jean Monnet, Nantes, 44035, France. yohann.foucher@univ-nantes.fr.|SPHERE (EA4275), Nantes University, Nantes, France. yohann.foucher@univ-nantes.fr.|Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. yohann.foucher@univ-nantes.fr.
authors.forename: Yohann
authors.initials: Y
authors.lastname: Foucher
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. monique.marguerite@chu-nantes.fr.
authors.forename: Monique
authors.initials: M
authors.lastname: Marguerite
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. Karine.NEAU@chu-nantes.fr.
authors.forename: Karine
authors.initials: K
authors.lastname: Neau
authors.affiliation: ITUN and Inserm U1064, Nantes University, 30 Boulevard Jean Monnet, Nantes, 44035, France. emmanuelle.papuchon@chu-nantes.fr.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Papuchon
authors.affiliation: ITUN and Inserm U1064, Nantes University, 30 Boulevard Jean Monnet, Nantes, 44035, France. pascal.daguin@chu-nantes.fr.
authors.forename: Pascal
authors.initials: P
authors.lastname: Daguin
authors.affiliation: Néphrologie, Transplantation et Immunologie Clinique, Hôpital Edouard Herriot, Lyon, France. emmanuel.morelon@chu-lyon.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Morélon
authors.affiliation: Service de Néphrologie, Dialyse et Transplantation, Hôpital Lapeyronie and Université Montpellier I, Montpellier, France. g-mourad@chu-montpellier.fr.
authors.forename: Georges
authors.initials: G
authors.lastname: Mourad
authors.affiliation: Service de Néphrologie, Hôpital Pasteur, Nice, France. cassuto.e@chu-nice.fr.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Cassuto
authors.affiliation: Service de Transplantation Rénale, CHU Brabois, Nancy, France. m.ladriere@chu-nancy.fr.
authors.forename: Marc
authors.initials: M
authors.lastname: Ladrière
authors.affiliation: Service de Transplantation Rénale et de Soins Intensifs, Hôpital Necker, APHP and Universités Paris Descartes et Sorbonne Paris Cité, Paris, France. christophe.legendre@nck.ap-hop-paris.fr.
authors.forename: Christophe
authors.initials: C
authors.lastname: Legendre
authors.affiliation: ITUN and Inserm U1064, Nantes University, 30 Boulevard Jean Monnet, Nantes, 44035, France. magali.giral@chu-nantes.fr.|SPHERE (EA4275), Nantes University, Nantes, France. magali.giral@chu-nantes.fr.|Centre d'Investigation Clinique en Biothérapie, Nantes University Hospital, Nantes, France. magali.giral@chu-nantes.fr.|CENTAURE Fondation, Nantes, France. magali.giral@chu-nantes.fr.
authors.forename: Magali
authors.initials: M
authors.lastname: Giral
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D000961:Antilymphocyte Serum / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D000077552:Basiliximab; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D004334:Drug Administration Schedule; D016527:Drug Costs; D005602:France / Q000453:epidemiology; D006785:Hospitals, University; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D015994:Incidence; D007676:Kidney Failure, Chronic / Q000601:surgery*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000191:economics; D011237:Predictive Value of Tests; D055031:Primary Graft Dysfunction / Q000175:diagnosis / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D019564:Unnecessary Procedures / Q000191:economics
chemical_list: D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab