Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2005
Sample size
Target
Accrual to date
Final
342
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00101738