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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00048152
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00048152