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

Completed · Phase 2 · Has a placebo group

Conditions studied: Kidney Transplantation

In brief

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

Key facts

Study ID

NCT03663335

Run by

Novartis Pharmaceuticals

People needed

418

Starts

2018-11-28

Expected to finish

2021-10-29

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Corrientes, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Camperdown, New South Wales, Australia
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — Clayton, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.