NCT01950819 - Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) | Biotech Hunter

Enrollment

2,037

Participants

Timeline

Start Date

December 3, 2013

Primary Completion Date

February 1, 2017

Study Completion Date

January 17, 2018

Conditions

End Stage Renal Disease (ESRD)Chronic Kidney Disease (CKD)HemodialysisRenal Replacement TherapyRenal Transplantation

Interventions

BIOLOGICAL

Induction therapy

All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.

DRUG

Corticosteroids

All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.

DRUG

EVR+rCNI

Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

DRUG

MPA+sCNI

Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Trial Locations (184)

652

Novartis Investigative Site, Saida

1000

Novartis Investigative Site, Zagreb

Novartis Investigative Site, Ljubljana

1070

Novartis Investigative Site, Brussels

1101

Novartis Investigative Site, Quezon City

1431

Novartis Investigative Site, Sofia

2031

Novartis Investigative Site, Randwick

2050

Novartis Investigative Site, Camperdown

2145

Novartis Investigative Site, Westmead

2650

Novartis Investigative Site, Edegem

3000

Novartis Investigative Site, Leuven

3010

Novartis Investigative Site, Bern

3050

Novartis Investigative Site, Parkville

3084

Novartis Investigative Site, Heidelberg

3168

Novartis Investigative Site, Clayton

4000

Novartis Investigative Site, Liège

4102

Novartis Investigative Site, Woolloongabba

5000

Novartis Investigative Site, Adelaide

5800

Novartis Investigative Site, Maastricht

6009

Novartis Investigative Site, Nedlands

6020

Novartis Investigative Site, Innsbruck

6150

Novartis Investigative Site, Murdoch

7925

Novartis Investigative Site, Cape Town

10000

Novartis Investigative Site, Zagreb

10002

Novartis Investigative Site, Taipei

10126

Novartis Investigative Site, Torino

10400

Novartis Investigative Site, Ratchathewi

Novartis Investigative Site, Bangkok

10467

Novartis Investigative Site, The Bronx

11000

Novartis Investigative Site, Belgrade

11159

Novartis Investigative Site, Riyadh

11527

Novartis Investigative Site, Athens

12203

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

14186

Novartis Investigative Site, Stockholm

14215

Novartis Investigative Site, Buffalo

15215

Novartis Investigative Site, Dammam

18000

Novartis Investigative Site, Niš

18014

Novartis Investigative Site, Granada

20162

Novartis Investigative Site, Milan

21201

Novartis Investigative Site, Baltimore

21499

Novartis Investigative Site, Jeddah

22908

Novartis Investigative Site, Charlottesville

27157

Novartis Investigative Site, Winston-Salem

27599

Novartis Investigative Site, Chapel Hill

27710

Novartis Investigative Site, Durham

28034

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28100

Novartis Investigative Site, Novara

29425

Novartis Investigative Site, Charleston

30625

Novartis Investigative Site, Hanover

34093

Novartis Investigative Site, Istanbul

34295

Novartis Investigative Site, Montpellier

34346

Novartis Investigative Site, Hannover Muenden

34394

Novartis Investigative Site, Mecidiyekoy/Istanbul

35128

Novartis Investigative Site, Padua

35233

Novartis Investigative Site, Birmingham

37044

Novartis Investigative Site, Tours

38320

Novartis Investigative Site, San Cristóbal de La Laguna

39008

Novartis Investigative Site, Santander

40138

Novartis Investigative Site, Bologna

40705

Novartis Investigative Site, Taichung

43100

Novartis Investigative Site, Parma

43210

Novartis Investigative Site, Columbus

44195

Novartis Investigative Site, Cleveland

44610

Novartis Investigative Site, Guadalajara

45147

Novartis Investigative Site, Essen

46017

Novartis Investigative Site, Valencia

48202

Novartis Investigative Site, Detroit

49100

Novartis Investigative Site, Petah Tikva

50009

Novartis Investigative Site, Zaragoza

50589

Novartis Investigative Site, Kuala Lumpur

51000

Novartis Investigative Site, Rijeka

51092

Novartis Investigative Site, Reims

51109

Novartis Investigative Site, Cologne

53100

Novartis Investigative Site, Siena

53226

Novartis Investigative Site, Milwaukee

53705

Novartis Investigative Site, Madison

60612

Novartis Investigative Site, Chicago

63110

Novartis Investigative Site, St Louis

64239

Novartis Investigative Site, Tel Aviv

67655

Novartis Investigative Site, Kaiserslautern

68100

Novartis Investigative Site, Selangor Darul Ehsan

69120

Novartis Investigative Site, Heidelberg

70124

Novartis Investigative Site, Bari

70421

Novartis Investigative Site, Tainan City

75015

Novartis Investigative Site, Paris

75246

Novartis Investigative Site, Dallas

76104

Novartis Investigative Site, Fort Worth

77030

Novartis Investigative Site, Houston

80045

Novartis Investigative Site, Aurora

80210

Novartis Investigative Site, Denver

81377

Novartis Investigative Site, München

81675

Novartis Investigative Site, München

84132

Novartis Investigative Site, Salt Lake City

90033

Novartis Investigative Site, Los Angeles

90048

Novartis Investigative Site, Los Angeles

92123

Novartis Investigative Site, San Diego

92354

Novartis Investigative Site, Loma Linda

93053

Novartis Investigative Site, Regensburg

94115

Novartis Investigative Site, San Francisco

97517

Novartis Investigative Site, Banská Bystrica

98195

Novartis Investigative Site, Seattle

123182

Novartis Investigative Site, Moscow

129010

Novartis Investigative Site, Moscow

166830

Novartis Investigative Site, El Achrafiyé

169608

Novartis Investigative Site, Singapore

350086

Novartis Investigative Site, Krasnodar

404120

Novartis Investigative Site, Volzhskiy

603000

Novartis Investigative Site, Nizhny Novgorod

620109

Novartis Investigative Site, Yekaterinburg

632004

Novartis Investigative Site, Vellore

1600190

Novartis Investigative Site, Lisbon

8207257

Novartis Investigative Site, Santiago

95817-1460

Novartis Investigative Site, Sacramento

94143-0116

Novartis Investigative Site, San Francisco

02114

Novartis Investigative Site, Boston

02215

Novartis Investigative Site, Boston

01805

Novartis Investigative Site, Burlington

48109-0331

Novartis Investigative Site, Ann Arbor

07039

Novartis Investigative Site, Livingston

44106-5048

Novartis Investigative Site, Cleveland

17105-8700

Novartis Investigative Site, Harrisburg

02903

Novartis Investigative Site, Providence

37212-3139

Novartis Investigative Site, Nashville

77030-2400

Novartis Investigative Site, Houston

C1181ACH

Novartis Investigative Site, CABA

C1107BEA

Novartis Investigative Site, San Martín

W3400ABH

Novartis Investigative Site, Buenos Aires

W3400

Novartis Investigative Site, Corrientes

X5016KEH

Novartis Investigative Site, Córdoba

X5016KET

Novartis Investigative Site, Córdoba

S3000EPV

Novartis Investigative Site, Santa Fe

A-4010

Novartis Investigative Site, Linz

90020-090

Novartis Investigative Site, Porto Alegre

04038-002

Novartis Investigative Site, São Paulo

05403 000

Novartis Investigative Site, São Paulo

Unknown

Novartis Investigative Site, Santiago de Cali

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Al Mansurah

Novartis Investigative Site, Kuwait City

Novartis Investigative Site, Saida

Novartis Investigative Site, Groningen

Novartis Investigative Site, Nijmegen

Novartis Investigative Site, Novi Sad

656 91

Novartis Investigative Site, Brno

140 00

Novartis Investigative Site, Prague

06001

Novartis Investigative Site, Nice

04103

Novartis Investigative Site, Leipzig

546 42

Novartis Investigative Site, Thessaloniki

106 76

Novartis Investigative Site, Athens

265 00

Novartis Investigative Site, Pátrai

560 055

Novartis Investigative Site, Bangalore

400 016

Novartis Investigative Site, Mumbai

110 017

Novartis Investigative Site, New Delhi

00144

Novartis Investigative Site, Roma

00168

Novartis Investigative Site, Roma

466-8650

Novartis Investigative Site, Nagoya

470 1192

Novartis Investigative Site, Toyoake

260-8712

Novartis Investigative Site, Chiba

3508 GA

Novartis Investigative Site, Utrecht

1105 AZ

Novartis Investigative Site, Amsterdam

2333 ZA

Novartis Investigative Site, Leiden

0424

Novartis Investigative Site, Oslo

70-111

Novartis Investigative Site, Szczecin

80 952

Novartis Investigative Site, Gdansk

60-355

Novartis Investigative Site, Poznan

60-479

Novartis Investigative Site, Poznan

2790-134

Novartis Investigative Site, Carnaxide

3000 075

Novartis Investigative Site, Coimbra

1069-166

Novartis Investigative Site, Lisbon

4200 319

Novartis Investigative Site, Porto

833 05

Novartis Investigative Site, Bratislava

04166

Novartis Investigative Site, Košice

03659

Novartis Investigative Site, Martin

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08003

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

SE-413 45

Novartis Investigative Site, Gothenburg

751 85

Novartis Investigative Site, Uppsala

07070

Novartis Investigative Site, Antalya