Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00048152




Registration number
NCT00048152
Ethics application status
Date submitted
24/10/2002
Date registered
25/10/2002
Date last updated
2/11/2016

Titles & IDs
Public title
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
Scientific 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
Secondary ID [1] 0 0
M67005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Corticosteroids
Treatment: Drugs - Neoral
Treatment: Drugs - Neoral
Treatment: Drugs - Zenapax
Treatment: Drugs - mycophenolate mofetil [CellCept]

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -


Treatment: Drugs: Corticosteroids
As prescribed

Treatment: Drugs: Neoral
Low dose (target trough level 50-100ng/mL)

Treatment: Drugs: Neoral
Standard dose (target trough level 150-300ng/mL)

Treatment: Drugs: Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks

Treatment: Drugs: mycophenolate mofetil [CellCept]
1g po bid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Renal function (as measured by GFR)
Timepoint [1] 0 0
12 months post-transplant
Secondary outcome [1] 0 0
Patient and graft survival \n
Timepoint [1] 0 0
12 months post-transplant
Secondary outcome [2] 0 0
Proportion of patients with biopsy-proven rejection; treatment failure.
Timepoint [2] 0 0
6 and 12 months post-transplant
Secondary outcome [3] 0 0
AEs, OIs, malignancies, deaths
Timepoint [3] 0 0
Throughout study

Eligibility
Key inclusion criteria
* adult patients greater than 18 years of age
* recipients of primary kidney transplant
* single-organ recipients (kidney only)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* previous treatment with Zenapax
* history of malignancy (except localized skin cancer)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
539
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Saskatchewan
Country [14] 0 0
France
State/province [14] 0 0
Vandoeuvre-les-nancy
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Hannover
Country [17] 0 0
Germany
State/province [17] 0 0
Muenster
Country [18] 0 0
Mexico
State/province [18] 0 0
Mexico City
Country [19] 0 0
Mexico
State/province [19] 0 0
Monterrey
Country [20] 0 0
Norway
State/province [20] 0 0
Oslo
Country [21] 0 0
Poland
State/province [21] 0 0
Warszawa
Country [22] 0 0
Poland
State/province [22] 0 0
Wroclaw
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Córdoba
Country [25] 0 0
Spain
State/province [25] 0 0
Malaga
Country [26] 0 0
Spain
State/province [26] 0 0
Santander
Country [27] 0 0
Spain
State/province [27] 0 0
Valencia
Country [28] 0 0
Sweden
State/province [28] 0 0
Goeteborg
Country [29] 0 0
Sweden
State/province [29] 0 0
Malmoe
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Birmingham
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Glasgow
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00048152