NCT01888432 - Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants | Biotech Hunter

Enrollment

285

Participants

Timeline

Start Date

September 25, 2013

Primary Completion Date

October 19, 2016

Study Completion Date

April 21, 2018

Conditions

Liver Transplantation

Interventions

DRUG

Everolimus + reduced tacrolimus

Everolimus was initiated at Week 4 post transplantation. The dose was adjusted to maintain the everolimus trough blood levels between 3-8 ng/mL for the duration of the study. Tacrolimus was reduced to 3-5 ng/mL.

DRUG

Standard tacrolimus

Tacrolimus was initiated as soon as possible after transplantation according to approved labeling recommendations. The trough level should've been 5-15 ng/mL until randomization, 8-12 ng/mL from randomization until month 4 and after month 4 until end of study reduced to 6 -10 ng/mL.

Trial Locations (42)

10032

Novartis Investigative Site, New York

11211

Novartis Investigative Site, Riyadh

11217

Novartis Investigative Site, Taipei

13353

Novartis Investigative Site, Berlin

20162

Novartis Investigative Site, Milan

21201

Novartis Investigative Site, Baltimore

22908

Novartis Investigative Site, Charlottesville

24105

Novartis Investigative Site, Kiel

33305

Novartis Investigative Site, Taoyuan District

34394

Novartis Investigative Site, Mecidiyekoy/Istanbul

40447

Novartis Investigative Site, Taichung

44280

Novartis Investigative Site, Malatya

48202

Novartis Investigative Site, Detroit

55455

Novartis Investigative Site, Minneapolis

83301

Novartis Investigative Site, Kaohsiung City

90033

Novartis Investigative Site, Los Angeles

93053

Novartis Investigative Site, Regensburg

94143

Novartis Investigative Site, San Francisco

119260

Novartis Investigative Site, Singapore

123182

Novartis Investigative Site, Moscow

600006

Novartis Investigative Site, Chennai

600100

Novartis Investigative Site, Chennai

02114

Novartis Investigative Site, Boston

01805

Novartis Investigative Site, Burlington

M5G 2N2

Novartis Investigative Site, Toronto

Unknown

Novartis Investigative Site, Cairo

07740

Novartis Investigative Site, Jena

122 001

Novartis Investigative Site, Gurgaon

682 026

Novartis Investigative Site, Kochi

466 8560

Novartis Investigative Site, Nagoya

812-8582

Novartis Investigative Site, Fukuoka

734-8551

Novartis Investigative Site, Hiroshima

860-8556

Novartis Investigative Site, Kumamoto

606 8507

Novartis Investigative Site, Sakyo Ku

852-8501

Novartis Investigative Site, Nagasaki

700-8558

Novartis Investigative Site, Okayama

113 8655

Novartis Investigative Site, Bunkyo Ku

160-8582

Novartis Investigative Site, Shinjuku-ku

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul