NCT01025817 - Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients | Biotech Hunter

Enrollment

613

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions

Kidney Transplant

Interventions

DRUG

Everolimus and tacrolimus

"Everolimus:~* Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets~* Dose: 1.5 mg per day~* Frequency: 0.75 mg twice daily~Tacrolimus:~* Dose adjusted to maintain specific blood levels"

DRUG

mycophenolate mofetil and tacrolimus

Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels

Trial Locations (50)

10032

Novartis Investigative Site, New York

14215

Novartis Investigative Site, Buffalo

21201

Novartis Investigative Site, Baltimore

22908

Novartis Investigative Site, Charlottesville

23298

Novartis Investigative Site, Richmond

23507

Novartis Investigative Site, Norfolk

27710

Novartis Investigative Site, Durham

27834

Novartis Investigative Site, Greenville

29425

Novartis Investigative Site, Charleston

32804

Novartis Investigative Site, Orlando

33136

Novartis Investigative Site, Miami

33606

Novartis Investigative Site, Tampa

35233

Novartis Investigative Site, Birmingham

48073

Novartis Investigative Site, Royal Oak

48236

Novartis Investigative Site, Detroit

55455

Novartis Investigative Site, Minneapolis

60612

Novartis Investigative Site, Chicago

60637

Novartis Investigative Site, Chicago

63110

Novartis Investigative Site, St Louis

75246

Novartis Investigative Site, Dallas

76104

Novartis Investigative Site, Fort Worth

77030

Novartis Investigative Site, Houston

79430

Novartis Investigative Site, Lubbock

80045

Novartis Investigative Site, Aurora

84132

Novartis Investigative Site, Salt Lake City

90033

Novartis Investigative Site, Los Angeles

90048

Novartis Investigative Site, Los Angeles

90095

Novartis Investigative Site, Los Angeles

92103

Novartis Investigative Site, San Diego

92123

Novartis Investigative Site, San Diego

92868

Novartis Investigative Site, Orange

94115

Novartis Investigative Site, San Francisco

95817

Novartis Investigative Site, Sacramento

97239

Novartis Investigative Site, Portland

98195

Novartis Investigative Site, Seattle

99204

Novartis Investigative Site, Spokane

85742-5022

Novartis Investigative Site, Tucson

94143-0780

Novartis Investigative Site, San Francisco

02111

Novartis Investigative Site, Boston

01655

Novartis Investigative Site, Worcester

48109-0331

Novartis Investigative Site, Ann Arbor

48202-2689

Novartis Investigative Site, Detroit

68198-3285

Novartis Investigative Site, Omaha

07039

Novartis Investigative Site, Livingston

17105-8700

Novartis Investigative Site, Harrisburg

37212-3139

Novartis Investigative Site, Nashville

77555-0144

Novartis Investigative Site, Galveston

05401

Novartis Investigative Site, Burlington

H1T 2M4

Novartis Investigative Site, Montreal

H2L 4M1

Novartis Investigative Site, Montreal