Phase 2
Completed N=403
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT03663335 ↗Enrolled (actual)
403
Serious AEs
33.2%
Results posted
Mar 2026
Primary outcomePrimary: Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1) — 60.6; 38.6; 22.0 Percentage of participants
Summary
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1) |
60.6; 38.6; 22.0 | — |
| PRIMARY Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2) |
14.7; 11.1 | — |
| SECONDARY Cohort 1: Mean Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-transplantation |
58.83; 60.63; 54.12 | 0.103 |
| SECONDARY Cohort 2: Mean Change in Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-conversion |
4.30; 1.42 | 0.153 |
| SECONDARY Free CFZ533 Plasma Concentrations Over Time (Cohort 1) |
0.00; 0.00; 471.20; 441.67; 231.93; 205.16 | — |
| SECONDARY Free CFZ533 Plasma Concentrations Over Time (Cohort 2) |
0.00; 681.59; 181.81; 147.56; 127.55; 121.81 | — |
| SECONDARY Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1) |
109; 108; 2; 0; 104; 101 | — |
| SECONDARY Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2) |
70; 0; 68; 0; 69; 0 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03663335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.