A 12-month randomized, multiple dose, open-label, study evaluating safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of an anti-CD40 monoclonal antibody, CFZ533, in combination with mycophenolate mofetil (MMF) and corticosteroids (CS), with and without tacrolimus (Tac), in de novo renal transplant recipients - CCFZ533X2201

ovartis Pharma Services AG0 个研究点目标入组 306 人开始时间: 2015年11月25日最近更新: 2018年1月29日

适应症

试验速览

暂无简介。

•Main Inclusion Criteria:
•Written informed consent must be obtained before any assessment is performed.
•Recipients of a kidney transplant from a heartbeating deceased, living unrelated or nonhuman leukocyte antigen (HLA) identical living related donor.
•Recipients of a kidney with a cold ischemia time (CIT) < 30 hours.
•other protocol-defined inclusion criteria may apply
•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 276
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Main Exclusion Criteria:
•Recipients of an organ from a nonheart beating donor.
•ABO incompatible or complement dependent lymphocytotoxic (CDC) crossmatch positive transplant.
•Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication.
•Subjects at high immunological risk for rejection
•Subjects at risk for tuberculosis (TB)
•Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment.
•Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the
•national labeling information of these products (see local product label).
•other protocol-defined exclusion criteria may apply

发起方