NCT00983645 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

First MR, Gerber DA, Hariharan S, Kaufman DB, Shapiro R
Posttransplant diabetes mellitus in kidney allograft recipients: incidence, risk factors, and management. Transplantation. 2002 Feb 15;73(3):379-86.
Jindal RM, Hjelmesaeth J
Impact and management of posttransplant diabetes mellitus. Transplantation. 2000 Dec 15;70(11 Suppl):SS58-63. Review.
Knoll GA, Bell RC
Tacrolimus versus cyclosporin for immunosuppression in renal transplantation: meta-analysis of randomised trials. BMJ. 1999 Apr 24;318(7191):1104-7.
Neylan JF
Racial differences in renal transplantation after immunosuppression with tacrolimus versus cyclosporine. FK506 Kidney Transplant Study Group. Transplantation. 1998 Feb 27;65(4):515-23.
Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS
A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83.

A Prospective, Open-label, Randomized Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity

Clinical trial NCT00983645 - References