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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048152

Enrollment

539

Registered

2002-10-25

Start date

2000-12-31

Completion date

2006-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Brief summary

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.

Interventions

DRUGCorticosteroids

As prescribed

DRUGNeoral

Low dose (target trough level 50-100ng/mL)

DRUGZenapax

2mg/kg iv first dose, then 1mg/kg every 2 weeks

DRUGmycophenolate mofetil [CellCept]

1g po bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Renal function (as measured by GFR)	12 months post-transplant

Secondary

Measure	Time frame
Proportion of patients with biopsy-proven rejection; treatment failure.	6 and 12 months post-transplant
AEs, OIs, malignancies, deaths	Throughout study
Patient and graft survival \n	12 months post-transplant

Countries

Australia, Belgium, Canada, France, Germany, Mexico, Norway, Poland, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026