Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months

Outcome Description:

A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Institutional Review Board

Study ID:

20-04-003

NCT ID:

NCT00113269

Start Date:

May 2005

Completion Date:

March 2009

Related Keywords:

• Kidney Transplantation
• Treatment Effectiveness
• Treatment Efficacy
• Anti-rejection therapy
• Immunosuppression
• Therapy, antirejection
• Renal Transplantation
• Transplantation, Kidney
• Transplantation, Renal
• Grafting, Kidney