Clinical trial NCT00048152: A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Renal function (as measured by GFR)
timeFrame: 12 months post-transplant
Secondary outcomes:
measure: Patient and graft survival \n
timeFrame: 12 months post-transplant
measure: Proportion of patients with biopsy-proven rejection; treatment failure.
timeFrame: 6 and 12 months post-transplant
measure: AEs, OIs, malignancies, deaths
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Livingston
country: United States
state: New Jersey
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Falls Church
country: United States
state: Virginia
city: Adelaide
country: Australia
city: Sydney
country: Australia
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Saskatoon
country: Canada
state: Saskatchewan
city: Vandoeuvre-les-nancy
country: France
city: Berlin
country: Germany
city: Hannover
country: Germany
city: Muenster
country: Germany
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Oslo
country: Norway
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Malaga
country: Spain
city: Santander
country: Spain
city: Valencia
country: Spain
city: Goeteborg
country: Sweden
city: Malmoe
country: Sweden
city: Birmingham
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leicester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: