Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
NCT ID: NCT03663335
Last Updated: 2022-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
418 participants
INTERVENTIONAL
2018-11-28
2021-10-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
NCT02217410
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
NCT00106639
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
NCT00658359
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
NCT03781414
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
NCT03363945
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1/Cohort 1
CFZ533 dose A+ MMF + Corticosteroids
CFZ533 - MMF - CS
Comparison with standard of care immunosuppression
Arm 2/Cohort 1
CFZ533 dose B + MMF + Corticosteroids
CFZ533 - MMF - CS
Comparison with standard of care immunosuppression
Arm 3/Cohort 1
Control/Standard of Care: TAC + MMF + Corticosteroids
Tacrolimus - MMF - +/- corticosteroids
Standard of care immunosupprevive regimen
Arm 1/Cohort 2
CFZ533 dose C + MMF ± Corticosteroids
CFZ533 - MMF - CS
Comparison with standard of care immunosuppression
Arm 2/Cohort 2
Tac + MMF ± Corticosteroids
Tacrolimus - MMF - +/- corticosteroids
Standard of care immunosupprevive regimen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CFZ533 - MMF - CS
Comparison with standard of care immunosuppression
Tacrolimus - MMF - +/- corticosteroids
Standard of care immunosupprevive regimen
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Aurora, Colorado, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Kansas City, Kansas, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Seattle, Washington, United States
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Corrientes, , Argentina
Novartis Investigative Site
Córdoba, , Argentina
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Tours, , France
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Nagakute, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Tomigusuku, Okinawa, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Osaka, , Japan
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Utrecht, The Netherlands, Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Oslo, , Norway
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Novartis Investigative Site
Zaragoza, , Spain
Novartis Investigative Site
Gothenburg, , Sweden
Novartis Investigative Site
Uppsala, , Sweden
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-003607-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCFZ533A2201
Identifier Type: OTHER
Identifier Source: secondary_id
03663335
Identifier Type: OTHER
Identifier Source: secondary_id
CCFZ533A2201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.