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

A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)

ClinicalTrials.gov Identifier: NCT03663335

Novartis Reference Number: CCFZ533A2201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients.

This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.

Condition 
Kidney Transplant Rejection
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
681 participants
Start date 
Nov 28, 2018
Completion date 
Jul 28, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
CFZ533
Comparison with standard of care immunosuppression
Drug
Tacrolimus - MMF - +/- corticosteroids
Standard of care immunosupprevive regimen

Eligibility Criteria

Inclusion Criteria:

Written informed consent obtained before any assessment.
Male or female patient ≥ 18 years old.
Up to date vaccination as per local immunization schedules.
Recipients of a kidney transplant
Recipients of a primary kidney transplant from a heart-beating deceased, living unrelated or non-HLA identical living related donors.

Exclusion Criteria:

Multi-organ transplant recipients or prior kidney transplant.
Recipients of an organ from a non-heart beating donor.
Recipient of an organ from an HLA identical living related donor.
ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant
Recipients of kidneys from donors who are older than 65 years.
Recipients of kidneys from donors with terminal serum creatinine > 2 mg/dL.
Patients at high immunological risk for rejection
Patient who is anti-HIV positive, HBsAg-positive or anti-HCV positive (without proof of sustained viral response (SVR) after anti-HCV treatment).
Recipient of a kidney from a donor who tests positive for HIV, HBsAg/HBc positive or HCV.
A negative Epstein Barr virus (EBV) test.
Evidence of advanced liver disease (Child-Pugh C), or any sign of liver decompensation.
Patient with severe systemic infections, current or within the two weeks prior to randomization.
History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions.

Study Locations

United States
Novartis Investigative Site
Recruiting
Los Angeles, 90033
California
United States
Novartis Investigative Site
Recruiting
San Francisco, 94143 0116
California
United States
Novartis Investigative Site
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Aurora, 80045
Colorado
United States
Novartis Investigative Site
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Chicago, 60611
Illinois
United States
Novartis Investigative Site
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Chicago, 60612
Illinois
United States
Novartis Investigative Site
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Kansas City, 66103
Kansas
United States
Novartis Investigative Site
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Baltimore, 21201
Maryland
United States
Novartis Investigative Site
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Boston, 02114
Massachusetts
United States
Novartis Investigative Site
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Ann Arbor, 48109 5271
Michigan
United States
Novartis Investigative Site
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Detroit, 48202
Michigan
United States
Novartis Investigative Site
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Saint Louis, 63110
Missouri
United States
Novartis Investigative Site
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Livingston, 07039
New Jersey
United States
Novartis Investigative Site
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New York, 10029
New York
United States
Novartis Investigative Site
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Durham, 27710
North Carolina
United States
Novartis Investigative Site
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Cincinnati, 45219
Ohio
United States
Novartis Investigative Site
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Cincinnati, 45267-0585
Ohio
United States
Novartis Investigative Site
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Charleston, 29425
South Carolina
United States
Novartis Investigative Site
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Nashville, 37212-3139
Tennessee
United States
Novartis Investigative Site
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Dallas, 75246
Texas
United States
Novartis Investigative Site
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Salt Lake City, 84132
Utah
United States
Novartis Investigative Site
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Seattle, 98195
Washington
United States
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, W3400ABH
-
Argentina
Novartis Investigative Site
Recruiting
Cordoba, X5016KEH
-
Argentina
Novartis Investigative Site
Recruiting
Corrientes, W3400
-
Argentina
Australia
Novartis Investigative Site
Recruiting
Camperdown, 2050
New South Wales
Australia
Novartis Investigative Site
Recruiting
Adelaide, 5000
South Australia
Australia
Novartis Investigative Site
Recruiting
Clayton, 3168
Victoria
Australia
Belgium
Novartis Investigative Site
Withdrawn
Bruxelles, 1070
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90020-090
RS
Brazil
Novartis Investigative Site
Recruiting
São Paulo, 04038-002
SP
Brazil
Czechia
Novartis Investigative Site
Recruiting
Prague 4, 140 21
-
Czechia
Estonia
Novartis Investigative Site
Recruiting
Tartu, 51014
-
Estonia
France
Novartis Investigative Site
Recruiting
Bordeaux Cedex, 33076
-
France
Novartis Investigative Site
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Creteil, 94010
-
France
Novartis Investigative Site
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Grenoble, 38043
-
France
Novartis Investigative Site
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Lyon, 69437
-
France
Novartis Investigative Site
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Montpellier, 34295
-
France
Novartis Investigative Site
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Nantes Cedex, 44035
-
France
Novartis Investigative Site
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Paris cedex 15, 75015
-
France
Novartis Investigative Site
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Toulouse Cedex 4, 31054
-
France
Novartis Investigative Site
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Tours, 37044
-
France
Germany
Novartis Investigative Site
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Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
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Berlin, 13353
-
Germany
Novartis Investigative Site
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Dresden, 01307
-
Germany
Novartis Investigative Site
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Erlangen, 91054
-
Germany
Novartis Investigative Site
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Essen, 45147
-
Germany
Novartis Investigative Site
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Hamburg, 20246
-
Germany
Novartis Investigative Site
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Heidelberg, 69120
-
Germany
Novartis Investigative Site
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Muenster, 48149
-
Germany
Hungary
Novartis Investigative Site
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Budapest, 1085
-
Hungary
Novartis Investigative Site
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Debrecen, 4032
-
Hungary
Novartis Investigative Site
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Szeged, 6720
-
Hungary
Italy
Novartis Investigative Site
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Milano, 20132
MI
Italy
Novartis Investigative Site
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Padova, 35128
PD
Italy
Novartis Investigative Site
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Roma, 00133
RM
Italy
Novartis Investigative Site
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Roma, 00168
RM
Italy
Novartis Investigative Site
Recruiting
Siena, 53100
SI
Italy
Japan
Novartis Investigative Site
Recruiting
Nagakute-city, 480-1195
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya-city, 466-8650
Aichi
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
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Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
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Sapporo-city,
Hokkaido
Japan
Novartis Investigative Site
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Yokohama city, 232 0024
Kanagawa
Japan
Novartis Investigative Site
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Kumamoto-city, 861-8520
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Tomigusuku, 901-0224
Okinawa
Japan
Novartis Investigative Site
Recruiting
Suita city, 565 0871
Osaka
Japan
Novartis Investigative Site
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Osaka, 545-8586
-
Japan
Korea, Republic of
Novartis Investigative Site
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Seoul, 03080
-
Korea, Republic of
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3508 GA
The Netherlands
Netherlands
Novartis Investigative Site
Recruiting
Groningen, 9713 GZ
-
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3000 CA
-
Netherlands
Norway
Novartis Investigative Site
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Oslo, 0424
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Norway
Slovakia
Novartis Investigative Site
Recruiting
Martin, 03659
-
Slovakia
Spain
Novartis Investigative Site
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Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
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Barcelona, 08035
Cataluña
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Cataluña
Spain
Novartis Investigative Site
Recruiting
L'Hospitalet de Llobregat, 08907
Cataluña
Spain
Novartis Investigative Site
Recruiting
Palma de Mallorca, 07014
Islas Baleares
Spain
Novartis Investigative Site
Withdrawn
Madrid, 28041
-
Spain
Novartis Investigative Site
Recruiting
Zaragoza, 50009
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Spain
Sweden
Novartis Investigative Site
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Göteborg, SE-413 45
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Sweden
Novartis Investigative Site
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Uppsala, 751 85
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Sweden
United Kingdom
Novartis Investigative Site
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Glasgow, G51 4TF
-
United Kingdom
Novartis Investigative Site
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London, SW17 0QT
-
United Kingdom
Novartis Investigative Site
Recruiting
Manchester, M13 9WL
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United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]