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/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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maine
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United States of America
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Massachusetts
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United States of America
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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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Pennsylvania
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Rhode Island
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South Carolina
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United States of America
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Texas
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Argentina
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Capital Ferderal
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Argentina
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Buenos Aires
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Argentina
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Ciudad de Bs As
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Argentina
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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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Canada
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Quebec
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Chile
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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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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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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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Italy
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Torino
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Norway
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Oslo
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Portugal
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Carnaxide-lisboa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Singapore
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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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Spain
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Madrid
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Spain
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Santander
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Spain
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Valencia
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Sweden
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Uppsala
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Taiwan
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Taipei
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Turkey
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Antalya
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Glasgow
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United Kingdom
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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
Trial website
Trial related presentations / publications
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

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/NCT00137345