NCT01187953 - Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx | Biotech Hunter

Enrollment

543

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2014

Conditions

Renal Failure

Interventions

DRUG

Prograf (tacrolimus)

Administered per current product labeling

DRUG

LCP-Tacro

Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

Trial Locations (86)

1142

Clinical Site 64112, Auckland

2050

Clinical Site 61101, Camperdown

3050

Clinical Site 61104, Parkville

3168

Clinical Site 61100, Clayton

5011

Clinical Site 61105, Woodville

6000

Clinical Site 61106, Perth

6009

Clinical Site 61102, Nedlands

6021

Clinical Site 64121, Wellington South

10016

Clinical Site 1050, New York

10029

Clinical Site 1019, New York

10065

Clinical Site 1025, New York

10117

Clinical Site 49137, Berlin

10467

Clinical Site 1035, The Bronx

10595

Clinical Site 1010, Valhalla

11000

Clinical Site 381140, Belgrade

11733

Clinical Site 1040, East Setauket

12208

Clinical Site 1060, Albany

14000

Clinical Site 52183, Mexico City

14080

Clinical Site 52182, Mexico City

14203

Clinical Site 1042, Buffalo

18000

Clinical Site 381141, Niš

19102

Clinical Site 1023, Philadelphia

20230

Clinical Site 52184, Aguascalientes

21000

Clinical Site 381142, Novi Sad

23298

Clinical Site 1027, Richmond

27599

Clinical Site 1051, Chapel Hill

27710

Clinical Site 1032, Durham

27834

Clinical Site 1058, Greenville

29425

Clinical Site 1012, Charleston

29609

Clinical Site 33132, Brest

30309

Clinical Site 1055, Atlanta

31059

Clinical Site 33134, Toulouse

32610

Clinical Site 1036, Gainesville

32804

Clinical Site 1038, Orlando

33136

Clinical Site 1013, Miami

33606

Clinical Site 1006, Tampa

35294

Clinical Site 1020, Birmingham

37232

Clinical Site 1047, Nashville

42000

Clinical Site 33136, Saint-Etienne

44106

Clinical Site 1005, Cleveland

45122

Clinical Site 49139, Essen

48236

Clinical Site 1018, Detroit

53226

Clinical Site 1008, Milwaukee

53792

Clinical Site 1046, Madison

60612

Clinical Site 1053, Chicago

61603

Clinical Site 1056, Peoria

62448

Clinical Site 52181, Cuernavaca, MOR

70112

Clinical Site 1026, New Orleans

77030

Clinical Site 1029, Houston

78229

Clinical Site 1039, San Antonio

80220

Clinical Site 1011, Denver

90024

Clinical Site 1009, Los Angeles

92103

Clinical Site 1045, San Diego

92123

Clinical Site 1049, San Diego

92354

Clinical Site 1031, Loma Linda

94115

Clinical Site 1044, San Francisco

95817

Clinical Site 1022, Sacremento

119074

Clinical Site 65127, Singapore

138736

Clinical Site 92113, Seoul

169608

Clinical Site 65126, Singapore

06520

Clinical Site 1003, New Haven

04102

Clinical Site 1052, Portland

02111

Clinical Site 1014, Boston

07601

Clinical Site 1048, Hackensack

07039

Clinical Site 1037, Livingston

08901

Clinical Site 1033, New Brunswick

17105-8700

Clinical Site 1054, Harrisburg

02903

Clinical Site 1021, Providence

78215-2035

Clinical Site 1061, San Antonio

C1425APQ

Clinical Site 54163, Buenos Aires

X5004CDT

Clinical Site 54164, Córdoba

36036-330

Clinical Site 55178, Juiz de Fora

90020-090

Clinical Site 55172, Porto Alegre, Rio Grande Do Sul

90035-903

Clinical Site 55179, Porto Alegre, Rio Grande Do Sul

14048-900

Clinical Site 55175, Ribeirão Preto

21041-030

Clinical Site 55173, Rio de Janeiro

04038-002

Clinical Site 55171, São Paulo

06002

Clinical Site 33131, Nice

00133

Clinical Site 39144, Roma

85-064

Clinical Site 48151, Bydgoszcz

70-111

Clinical Site 48148, Szczecin

02-006

Clinical Site 48149, Warsaw

08003

Clinical Site 34155, Barcelona

08035

Clinical Site 34157, Barcelona

08907

Clinical Site 34151, L'Hospitalet de Llobregat

Unknown

Clinical Site 46161, Malmo