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)

CompletadoFase 2ClinicalTrials.gov

ID: NCT03663335RENIS: IS002375Tipo: INTERVENTIONALInicio: 28 de nov de 2018Fin estimado: 29 de oct de 2021

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

CFZ533 - MMF - CS

Comparison with standard of care immunosuppression

drug

Tacrolimus - MMF - +/- corticosteroids

Standard of care immunosupprevive regimen

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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