Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus, LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf® will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study will be treated with assigned study drug and followed for one year for patient survival and the incidence of graft rejection or graft loss.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.|
- Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.
Active Comparator: Prograf (tacrolimus)
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
Other Name: tacrolimus
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP-Tacro tablets (tacrolimus, LifeCycle Pharma A/S, Horsholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult make and female kidney transplant patients. Recipients of kidney transplant 3 months to 5 years before Screening and on a stable dose of Prograf will be randomly assigned to be converted from Prograf twice daily to LCP-Tacro once daily or to remain on maintenance therapy with Prograf twice daily. There will be 11 study visits in the Treatment period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817206
|United States, California|
|California Institute of Renal Research/ Sharp Memorial|
|San Diego, California, United States, 92123|
|Principal Investigator:||Steven Steinberg, M.D.||Claifornia Institute of Renal Research/Sharp Memorial|