A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.
Sponsor study identifier
interventional
280
2 countries
13
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Study Completion
November 2006
Actual (reported)Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 19, 2005
Actual (reported)November 2006
Actual (reported)November 2006
Actual (reported)Calculated creatinine clearance at 12 months post transplantation for patients on therapy.
Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Curitiba, Paraná, 80730-150, Brazil
Rio de Janeiro, Rio de Janeiro, 21041-030, Brazil
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Ribeirao Preto, Rio Grande do Sul, 14048-900, Brazil
São José do Rio Preto, São Paulo, 15015-200, Brazil
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
For Brazil, xavierl@wyeth.com
Trial Manager
For Mexico, gomezlj@wyeth.com
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
Contact the study team to confirm eligibility.
São Paulo, São Paulo, 01323-001, Brazil
São Paulo, São Paulo, 04038-002, Brazil
São Paulo, São Paulo, 05403-000, Brazil
Chihuahua City, Chihuahua, Mexico
Torreón, Coahuila, 27000, Mexico
Mexico City DF, 14000, Mexico
Study Completion
November 2006
Actual (reported)Last Updated
March 8, 2011
Record last verified: 2007-12
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Source: ClinicalTrials.gov.
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