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

NCT03663335

CompletedPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Kidney Transplantation

Interventions: CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS), Tacrolimus, Induction therapy: basiliximab

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France

This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

Key inclusion criteria for both cohorts

* Written informed consent obtained before any assessment.
* Male or female patient ≥ 18 years old.
* Up to date vaccination as per local immunization schedules.

Key inclusion criteria specific to Cohort 1:

* Recipients of a primary kidney transplant from a brain-dead donor, living unrelated or non-human leukocyte antigen (HLA) identical living related donors.
* Recipients of a kidney with a cold ischemia time \< 24 hours.

Key inclusion criteria specific to Cohort 2:

* Recipients of a primary graft received 6 to 24 months prior enrollment, on a regimen containing TAC+MMF/ Enteric-coated mycophenolate sodium (EC-MPS)±corticosteroids (CS).
* Patients with an actual eGFR according to Modification of Diet in Renal Disease (MDRD-4) ≥ 45 mL/min/1.73m2.

Exclusion Criteria:

Key exclusion criteria for both cohorts

* Recipient who tests positive for anti-HIV, HBsAg or anti-HCV (without proof of sustained viral response (SVR12) after anti-HCV treatment) within 28 days prior to baseline visit.
* Recipient who tests negative for Epstein Barr virus (EBV) within 28 days prior to baseline visit.
* 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.
* Patients who weighed less than 30 kg or more than 180 kg.

Key exclusion criteria specific to Cohort 1:

* Multi-organ transplant recipients, including en bloc and dual kidney transplantation, or prior kidney transplant
* Recipients of an organ from a donor after cardiac death.
* Recipient of an organ from an HLA identical living related donor.
* ABO incompatible or complement-dependent lymphocytotoxic crossmatch positive transplant (isolated positive B cell crossmatches were not an exclusion criterion).
* Recipients of kidneys from donors who were older than \>65 years.
* Recipients of kidneys from donors with terminal serum creatinine \> 2 mg/dL.
* Patients at high immunological risk for rejection as determined for assessment of anti-donor reactivity:
* high panel reactive antibodies\> 20% or
* Presence of pre-formed DSA. Results 12 weeks prior to enrollment were acceptable if no blood transfusion or abortion occurred during this period.
* Recipient of a kidney from a donor who tests positive for HIV, HBsAg or HCV.

Key exclusion criteria to Cohort 2

* Recipients of a kidney re-transplant.
* Recipient of a multi-organ transplant, including en bloc and dual kidney transplantation.
* DSA within 12 weeks prior enrollment.
* eGFR decline ≥10.0 mL/min within 12 weeks prior enrollment.
* Ongoing rejection or rejection that required treatment within 12 weeks prior enrollment.
* Severe humoral and/or cellular rejection (BANFF ≥ IIb) within 12 weeks before enrollment.
* Proteinuria \> 1 g/day or UPCR \>1.2 mg/mg at time of enrollment
Locations (74)
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States
  • Buenos Aires, Argentina
  • Corrientes, Argentina
  • Córdoba, Argentina
  • Camperdown, New South Wales, Australia
  • Adelaide, South Australia, Australia
  • Clayton, Victoria, Australia
  • Leuven, Belgium
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Vancouver, British Columbia, Canada
  • Prague, Czechia
  • Bordeaux, France
  • Créteil, France
  • Grenoble, France
  • + 44 more on CT.gov