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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00101738




Registration number
NCT00101738
Ethics application status
Date submitted
12/01/2005
Date registered
13/01/2005
Date last updated
31/01/2011

Titles & IDs
Public title
Freedom Study: Myfortic in Kidney Transplant Patients
Scientific title
Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids
Secondary ID [1] 0 0
CERL080A2404
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 - Myfortic

Treatment: Drugs: Myfortic


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Calculated glomerular filtration rate after 12 months treatment
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Patient and graft survival after 12 months.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Incidence of AEs and SAEs after 3 and 12 months.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Percentage of patients free of steroids at 12 months
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- Males and females aged 18 to 75 years.

- Recipients of first, heart-beating cadaveric, living unrelated or living related
non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as
primary immunosuppression.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and
pancreas) or previous transplant with any other organ.

- Kidneys from non-heart beating donors or HLA identical living related donors.

- ABO incompatibility against the donor.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Cordoba
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Canada
State/province [16] 0 0
Saskatchewan
Country [17] 0 0
Germany
State/province [17] 0 0
Frankfurt am Main
Country [18] 0 0
Germany
State/province [18] 0 0
Koeln
Country [19] 0 0
Italy
State/province [19] 0 0
BA
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
New Zealand
State/province [21] 0 0
Grafton
Country [22] 0 0
Singapore
State/province [22] 0 0
Singapore
Country [23] 0 0
Spain
State/province [23] 0 0
L'hospitalet de Llobregat
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Oviedo
Country [26] 0 0
Taiwan
State/province [26] 0 0
Lin-Ko
Country [27] 0 0
Taiwan
State/province [27] 0 0
ROC
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Birmingham
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cardiff
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Coventry
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Newcastle Upon Tyne
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have
comparable kidney function results in kidney transplant patients.
Trial website
https://clinicaltrials.gov/show/NCT00101738
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Novartis
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
Other publications