Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti… (NCT03663335) | Clinical Trial Compass
CompletedPhase 2
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
United States418 participantsStarted 2018-11-28
Plain-language summary
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
Who can participate
Age range18 Years
SexALL
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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 recu…
What they're measuring
1
Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1)
Timeframe: 12 Months
2
Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2)