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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00137345




Registration number
NCT00137345
Ethics application status
Date submitted
25/08/2005
Date registered
29/08/2005
Date last updated
8/02/2013

Titles & IDs
Public title
Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients
Scientific title
A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients
Secondary ID [1] 0 0
B1741188
Secondary ID [2] 0 0
0468H1-318
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Non-inferiority of the composite of graft loss and death at 52 weeks
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
Timepoint [1] 0 0
Secondary outcome [2] 0 0
quality of life at 24, 52 and 104 weeks
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* Dialysis patients who will be receiving their first kidney transplant
* Weight over 88 pounds (lbs.)
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Very high cholesterol levels
* Obesity
* Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Parkville
Recruitment hospital [3] 0 0
- Randwick
Recruitment hospital [4] 0 0
- Westmead
Recruitment hospital [5] 0 0
- Woodville South
Recruitment hospital [6] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
SA 5011 - Woodville South
Recruitment postcode(s) [6] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Maine
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Massachusetts
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Michigan
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New York
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North Carolina
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Ohio
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Cordoba
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Austria
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Wien
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Canada
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Ontario
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Quebec
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Puente Alto
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Chile
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Santiago
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Chile
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Talca
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Chile
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Vina del Mar
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Cyprus
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Nicosia
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France
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Montpellier Cedex
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France
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Paris Cedex 15
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Germany
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Munster
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Athens
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Greece
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Thessaloniki
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Budapest
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Debrecen
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Pecs
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Hungary
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Szeged
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Italy
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Bari
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Italy
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Cagliari
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Torino
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Oslo
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Portugal
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Coimbra
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Lisboa
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Singapore
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South Africa
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Cape Town
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South Africa
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Johannesburg
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Spain
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Barcelona
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Spain
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La Coruã'a
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Spain
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La Laguna / Santa Cruz de Tenerife
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Madrid
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Spain
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Santander
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Valencia
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Uppsala
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Taipei
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Turkey
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Antalya
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Istanbul
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Izmir
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Glasgow
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Leicester
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
Trial website
https://clinicaltrials.gov/study/NCT00137345
Trial related presentations / publications
Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
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/NCT00137345