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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
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
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