NCT01064791 - Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients | Biotech Hunter

Enrollment

298

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions

Renal Transplantation

Interventions

DRUG

sotrastaurin (Dose 1) + tacrolimus + standard of care medications

sotrastaurin (100mg bid) + tacrolimus + standard of care medications

DRUG

sotrastaurin (Dose 2) + tacrolimus + standard of care medications

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

DRUG

sotrastaurin (Dose 3) + tacrolimus + standard of care medications

sotrastaurin (300mg bid) + tacrolimus + standard of care medications

DRUG

mycophenolic acid + tacrolimus + standard of care medications

mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Trial Locations (44)

1070

Novartis Investigative Site, Brussels

1082

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

2050

Novartis Investigative Site, Camperdown

3000

Novartis Investigative Site, Leuven

3050

Novartis Investigative Site, Melbourne

4102

Novartis Investigative Site, Woolloongabba

5000

Novartis Investigative Site, Adelaide

6720

Novartis Investigative Site, Szeged

10098

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

20246

Novartis Investigative Site, Hamburg

30625

Novartis Investigative Site, Hanover

35233

Novartis Investigative Site, Birmingham

45147

Novartis Investigative Site, Essen

45219

Novartis Investigative Site, Cincinnati

48109

Novartis Investigative Site, Ann Arbor

51109

Novartis Investigative Site, Cologne

53792

Novartis Investigative Site, Madison

69120

Novartis Investigative Site, Heidelberg

80045

Novartis Investigative Site, Aurora

93053

Novartis Investigative Site, Regensburg

48202-2689

Novartis Investigative Site, Detroit

45267-0585

Novartis Investigative Site, Cincinnati

W3400

Novartis Investigative Site, Corrientes

X5016KEH

Novartis Investigative Site, Córdoba

X5022CPU

Novartis Investigative Site, Córdoba

90035-903

Novartis Investigative Site, Porto Alegre

04023-900

Novartis Investigative Site, São Paulo

V6Z 1Y6

Novartis Investigative Site, Vancouver

Unknown

Novartis Investigative Site, Santiago de Cali

8000 C

Novartis Investigative Site, Aarhus

3015 CE

Novartis Investigative Site, Rotterdam

3000-075

Novartis Investigative Site, Coimbra

1069-166

Novartis Investigative Site, Lisbon

4099-001

Novartis Investigative Site, Porto

120-752

Novartis Investigative Site, Seoul

138-736

Novartis Investigative Site, Seoul

SE-413 45

Novartis Investigative Site, Gothenburg

141 86

Novartis Investigative Site, Stockholm

751 85

Novartis Investigative Site, Uppsala

G11 6NT

Novartis Investigative Site, Glasgow

LE5 4PW

Novartis Investigative Site, Leicester

M13 9WL

Novartis Investigative Site, Manchester