This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

Official Title

A Randomized, Open-Label Study Comparing the Effects of Low-Dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab

Conditions

Kidney Transplantation

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • Renal function , as measured by glomerular filtration rate

Secondary Outcome Measures:

  • Efficacy: Patient and graft survival at 12 months, proportion of patients with biopsy-proven rejection, treatment failure 6 months and 12 months posttransplant Safety: AEs, opportunistic events, malignancies, deaths

Study Start

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • adult patients greater than 18 years of age
  • recipients of primary kidney transplant
  • single-organ recipients (kidney only)

Exclusion Criteria:

  • previous treatment with Zenapax
  • history of malignancy (except localized skin cancer)

Total Enrolment

Contact Details

Australian Locations:

  • ADELAIDE, 5011, Australia
  • SYDNEY, 2050, Australia

For more more information, refer to Hoffmann-La Roche Clinical Trial Registry