NCT00637143 - 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)

Jevnikar A, Arlen D, Barrett B, Boucher A, Cardella C, Cockfield SM, Rush D, Paraskevas S, Shapiro J, Shoker A, Yilmaz S, Zaltzman JS, Kiberd B
Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure. Transplantation. 2008 Oct 15;86(7):953-60. doi: 10.1097/TP.0b013e318186dd0c.

Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

Clinical trial NCT00637143 - References