A Multicenter, Randomized, Placebo-Controlled Investigator-Blind, Participant-Blind Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

CB Biopharma SR0 个研究点目标入组 12 人开始时间: 2018年11月7日最近更新: 2021年8月17日

研究概览

暂无简介。

•-Functioning living or deceased donor allograft >=1 year post-transplantation
•-Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (>=25% IF/TA)
•-Progressive loss decline in kidney function observed after the first year post-transplant, defined as estimated glomerular filtration rate (eGFR) decline of >=3 ml/min/year for at least 24 months prior to screening, with a minimum of 2 documented measurements per year (minimum of 4 documented measurements in the 24-month period, performed at least 1 month apart)
•-An eGFR >=30 mL/min/1.73 m^2 for a period of 6 months up to screening
•-Stable standard of care concomitant medication for 3 months prior to screening
•-Participant is male or female, >=18 years of age
•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 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•-Recipient of multi-organ transplant (with the exception of repeated kidney transplant recipients, and/or corneal transplant recipients)
•-Screening biopsy shows evidence of significant active antibody-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the Principal Investigator (PI)
•-Screening biopsy shows evidence of T cell-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the PI
•-Screening biopsy shows evidence of de novo or recurrent glomerular disease that may affect the conduct of the study (eg, require change in treatment) according to the PI
•-Proteinuria >=1500 mg/g at screening
•-Participant who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening
•-Participant has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of investigational medicinal product (IMP)
•-Participant has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer or history of delayed wound healing
•-Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening

发起方

CB Biopharma SR