A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients

Astellas

Status and phase: Terminated; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: FK778

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282230

03-0-165

Details and patient eligibility

About

A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
• Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.

Exclusion criteria

• Patient has received or is receiving an organ transplant other than kidney
• Patient has received a kidney transplant from a cadaveric donor >= 60 years of age.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)