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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03663335




Registration number
NCT03663335
Ethics application status
Date submitted
4/06/2018
Date registered
10/09/2018

Titles & IDs
Public title
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
Scientific title
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)
Secondary ID [1] 0 0
2017-003607-22
Secondary ID [2] 0 0
CCFZ533A2201
Universal Trial Number (UTN)
Trial acronym
CIRRUS I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CFZ533 - MMF - CS
Treatment: Drugs - Tacrolimus - MMF - +/- corticosteroids

Experimental: Arm 1/Cohort 1 - CFZ533 dose A+ MMF + Corticosteroids

Experimental: Arm 2/Cohort 1 - CFZ533 dose B + MMF + Corticosteroids

Active comparator: Arm 3/Cohort 1 - Control/Standard of Care: TAC + MMF + Corticosteroids

Experimental: Arm 1/Cohort 2 - CFZ533 dose C + MMF ± Corticosteroids

Active comparator: Arm 2/Cohort 2 - Tac + MMF ± Corticosteroids


Treatment: Other: CFZ533 - MMF - CS
Comparison with standard of care immunosuppression

Treatment: Drugs: Tacrolimus - MMF - +/- corticosteroids
Standard of care immunosupprevive regimen
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with composite event (BPAR, Graft Loss or Death)
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Cohorts 1 and 2-Mean eGFR over 12 months
Timepoint [1] 0 0
Baseline to month 12
Secondary outcome [2] 0 0
Cohorts 1 and 2-Cohorts 1 and 2-safety of CFZ533 regimens compared to a tacrolimus based regimen
Timepoint [2] 0 0
Baseline to month 12
Secondary outcome [3] 0 0
Cohorts 1 and 2-Cohorts 1 and 2 - tolerability of CFZ533 regimens compared to a tacrolimus based regimen
Timepoint [3] 0 0
Baseline to month 12
Secondary outcome [4] 0 0
Cohorts 1 and 2-pharmacokinetics of CFZ533 during the 60 months treatment period and explore the dose-exposure relationship
Timepoint [4] 0 0
Baseline to month 60
Secondary outcome [5] 0 0
Cohorts 1 and 2-immunogenicity of CFZ533 during the 60 months treatment period
Timepoint [5] 0 0
Baseline to month 60

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/10/2021
Sample size
Target
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Missouri
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North Carolina
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Ohio
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Corrientes
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Belgium
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Leuven
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Brazil
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RS
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Brazil
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SP
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Canada
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British Columbia
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Czechia
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Prague 4
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France
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Bordeaux Cedex
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France
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Creteil
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France
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Grenoble
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France
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Lyon
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France
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Nantes Cedex 1
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France
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Paris cedex 15
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France
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Toulouse Cedex 4
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France
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Tours
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Germany
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Bavaria
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Mainz
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Hungary
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Budapest
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Hungary
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Debrecen
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Italy
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MI
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Italy
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RM
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Japan
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Aichi
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Japan
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Hokkaido
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Okinawa
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Japan
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Osaka
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Netherlands
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The Netherlands
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Netherlands
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Groningen
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Netherlands
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Rotterdam
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Norway
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Oslo
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Spain
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Catalunya
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Spain
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Cataluña
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Spain
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Islas Baleares
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Spain
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Zaragoza
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Sweden
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Göteborg
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Sweden
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Uppsala
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Switzerland
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Bern
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
State/province [62] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03663335