A 12 month, partially-blinded, active-controlled, multicenter,randomized study evaluating efficacy, safety, tolerability,pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40monoclonal antibody, CFZ533, in de novo and maintenance kidneytransplant recipients (CIRRUS I) - CIRRUS I

ovartis Pharma AG0 个研究点目标入组 325 人开始时间: 2018年10月17日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•1.Male or female patient = 18 years old.
•2. Up to date vaccination
•3.Recipients of a primary kidney transplant from a brain-death donor (DBD), living unrelated or non-HLA identical living related donor (cohort1).
•4.Recipients of a kidney with a cold ischemia time (CIT) < 24 hours (cohort 1)
•5. Recipients of a primary graft received 6 to 24 months prior enrollment, on a regimen
•containing Tac+MMF±CS (Cohort 2)
•6.Patients with an actual eGFR = 45 mL/min/1.73m2 (Cohort 2)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 295
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1.Multi-organ transplant recipients or prior kidney transplant (cohort 1 and 2)
•2.Pregnant or nursing women (cohort 1 and 2)
•3.Women of child bearing potential unless using highly effective methods of contraception during dosing and 12 weeks after study medication has been stopped (cohort 1 and 2)
•4. Recipients of an organ from a donor after cardiac death (DCD) (cohort 1).
•5. Recipient of an organ from an HLA identical living related donor (cohort 1).
•6. Recipients of kidneys from donors who are older than 65 years (cohort 1).
•7.Patients at high immunological risk for rejection (cohort 1)
•8.DSA within 12 weeks prior enrollment (cohort 2)
•9. Ongoing rejection or rejection that required treatment within 12 weeks prior enrollment (cohort 2)
•10. Severe humoral and/or cellular rejection (BANFF = IIb) before enrollment (cohort 2)

发起方