A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids

Phase 4 Completed 1166 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

Timeline

Start: 2011-01-22
Primary completion: 2013-05-22
Completion: 2013-05-22

Publications

Mourad G, Glyda M, Albano L, Viklicky O, Merville P, Tyden G, Mourad M, Lohmus A, Witzke O, Christiaans MHL, Brown MW, Undre N, Kazeem G, Kuypers DRJ; Advagraf-based immunosuppression regimen examining new onset diabetes mellitus in kidney transplant recipients (ADVANCE) study investigators. Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1924-1934. doi: 10.1097/TP.0000000000001453.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylprednisolone	Other / unclassified	—	Intravenous
Subject	Prednisolone	Other / unclassified	—	Intravenous
Background	Basiliximab	Monoclonal antibody	—	—
Background	Mycophenolate Mofetil	Small molecule	—	Oral
Background	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.