Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Flavio Vincenti

Description

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.

Official 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)

Keywords

Kidney Transplant Rejection Renal transplantation, CFZ533, CNI-free immunosuppression, transplant rejection, allograft rejection. Tacrolimus CFZ533 Tacrolimus - MMF - +/- corticosteroids

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Novartis Investigative Site accepting new patients
    San Francisco California 94143 0116 United States
  • Novartis Investigative Site accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UCSF

  • Flavio Vincenti
    Professor, Medicine. Authored (or co-authored) 256 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03663335
Phase
Phase 2
Study Type
Interventional
Last Updated