Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation

Phase 4 Completed 60 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients 1 month after kidney transplantation.

Timeline

Start: 2012-04
Primary completion: 2012-06
Completion: 2012-06

Publications

Oh CK, Huh KH, Lee JS, Cho HR, Kim YS. Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation. Yonsei Med J. 2014 Sep;55(5):1341-7. doi: 10.3349/ymj.2014.55.5.1341.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tacrolimus	Small molecule	—	Oral
Background	Mycophenolate Mofetil	Small molecule	—	Oral

Indications

No indication recorded.