A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

Roche

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: mycophenolate mofetil [CellCept]; Drug: Zenapax; Drug: Corticosteroids; Drug: Neoral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048152

M67005

Details and patient eligibility

About

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.

Enrollment: 539 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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539 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: mycophenolate mofetil [CellCept]

Drug: Zenapax

Drug: Neoral

Drug: Corticosteroids

Drug: Neoral

2

Experimental group

Treatment:

Drug: mycophenolate mofetil [CellCept]

Drug: Zenapax

Drug: Neoral

Drug: Corticosteroids

Drug: Neoral

3

Experimental group

Treatment:

Drug: mycophenolate mofetil [CellCept]

Drug: Neoral

Drug: Corticosteroids

Drug: Neoral