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

COMPLETEDPHASE2

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)

NCT03663335•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (74)

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

Key Dates

Start Date

November 28, 2018

Primary Completion Date

October 29, 2021

Completion Date

October 29, 2021

Last Updated

June 13, 2022

Enrollment

418

ACTUAL participants

Conditions

Kidney Transplant Rejection

Interventions

CFZ533 - MMF - CS

BIOLOGICAL

Tacrolimus - MMF - +/- corticosteroids

DRUG

Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

NCT07006532

Kidney Transplant Rejection

View study

RECRUITING

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

NCT04736381

Kidney Transplant Rejection

View study

RECRUITINGNA

Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients

NCT04702022

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients

PRObiotics for KIdney Transplantation

Microbiome and Immunosuppression: The Mission Study

Observational Cohort Study Renal Transplantation University Hospitals Leuven