At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Open Label Study Comparing the Metabolic Control of Kidney Transplant Recipients With Type 2 Diabetes Receiving Either Prograf or Neoral as Part of a ATG Induction, Prednisone Free and Monitored MMF Immunosuppressive Regimen.
In Brief
A Phase 4 clinical trial evaluating Cyclosporin, Tacrolimus, and 1 other intervention for Kidney Transplant and 2 related conditions. Completed, enrolled 29 participants across 1 site.
Detailed Summary
Protocol Title: Randomized open label study comparing the metabolic control of first Kidney Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a ATG induction, prednisone free and blood monitored Cellcept immunosuppressive regimen. PURPOSE This is a single center medical research study to analyze post-transplant kidney recipients with pre-existing type 2 diabetes managed according to the recommended American Diabetes Association (ADA) guidelines. Prograf (Tac) and Neoral (CSA) are the two main medications to prevent rejection after transplantation. However, they may contribute to poorer diabetes control. The purpose of the study is to compare the effects of Prograf and Neoral on the control of Diabetes after kidney transplantation. In addition, all participants in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of transplantation instead of long term prednisone (steroids).
Study Details
Timeline
Interventions
Dose adjustment to pre-established targets
Dose adjustment to pre-established targets
therapeutic adjustment to target ADA criteria