Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

PHASE2CompletedINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

November 28, 2018

Primary Completion Date

October 29, 2021

Study Completion Date

October 29, 2021

Conditions
Kidney Transplant Rejection
Interventions
BIOLOGICAL

CFZ533 - MMF - CS

Comparison with standard of care immunosuppression

DRUG

Tacrolimus - MMF - +/- corticosteroids

Standard of care immunosupprevive regimen

Trial Locations (74)

1085

Novartis Investigative Site, Budapest

2050

Novartis Investigative Site, Camperdown

3000

Novartis Investigative Site, Leuven

3010

Novartis Investigative Site, Bern

3168

Novartis Investigative Site, Clayton

4032

Novartis Investigative Site, Debrecen

5000

Novartis Investigative Site, Adelaide

13353

Novartis Investigative Site, Berlin

20132

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

21201

Novartis Investigative Site, Baltimore

27710

Novartis Investigative Site, Durham

31054

Novartis Investigative Site, Toulouse

33067

Novartis Investigative Site, Bordeaux

37044

Novartis Investigative Site, Tours

38043

Novartis Investigative Site, Grenoble

44093

Novartis Investigative Site, Nantes

45147

Novartis Investigative Site, Essen

45219

Novartis Investigative Site, Cincinnati

48202

Novartis Investigative Site, Detroit

50009

Novartis Investigative Site, Zaragoza

55131

Novartis Investigative Site, Mainz

60611

Novartis Investigative Site, Chicago

60612

Novartis Investigative Site, Chicago

63110

Novartis Investigative Site, St Louis

66103

Novartis Investigative Site, Kansas City

69120

Novartis Investigative Site, Heidelberg

69437

Novartis Investigative Site, Lyon

75015

Novartis Investigative Site, Paris

75390

Novartis Investigative Site, Dallas

80045

Novartis Investigative Site, Aurora

90033

Novartis Investigative Site, Los Angeles

91054

Novartis Investigative Site, Erlangen

93053

Novartis Investigative Site, Regensburg

94010

Novartis Investigative Site, Créteil

98195

Novartis Investigative Site, Seattle

94143 0116

Novartis Investigative Site, San Francisco

02114

Novartis Investigative Site, Boston

45267-0585

Novartis Investigative Site, Cincinnati

W3400ABH

Novartis Investigative Site, Buenos Aires

W3400

Novartis Investigative Site, Corrientes

X5016KEH

Novartis Investigative Site, Córdoba

90020-090

Novartis Investigative Site, Porto Alegre

04038-002

Novartis Investigative Site, São Paulo

05403 000

Novartis Investigative Site, São Paulo

V6Z 1Y6

Novartis Investigative Site, Vancouver

140 21

Novartis Investigative Site, Prague

01307

Novartis Investigative Site, Dresden

00133

Novartis Investigative Site, Roma

480-1195

Novartis Investigative Site, Nagakute

466-8650

Novartis Investigative Site, Nagoya

060 8648

Novartis Investigative Site, Sapporo

Unknown

Novartis Investigative Site, Sapporo

232 0024

Novartis Investigative Site, Yokohama

861-8520

Novartis Investigative Site, Kumamoto

901-0224

Novartis Investigative Site, Tomigusuku

565 0871

Novartis Investigative Site, Suita

545-8586

Novartis Investigative Site, Osaka

LV 1002

Novartis Investigative Site, Riga

3508 GA

Novartis Investigative Site, Utrecht

9713 GZ

Novartis Investigative Site, Groningen

3000 CA

Novartis Investigative Site, Rotterdam

0424

Novartis Investigative Site, Oslo

03080

Novartis Investigative Site, Seoul

07014

Novartis Investigative Site, Palma de Mallorca

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

SE-413 45

Novartis Investigative Site, Gothenburg

751 85

Novartis Investigative Site, Uppsala

G51 4TF

Novartis Investigative Site, Glasgow

SW17 0QT

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY