CLINICAL TRIAL: GC1008 IN PATIENTS WITH TREATMENT RESISTANT IDIOPATHIC FSGS

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目的：确定难治性特发性FSGS和肾病范围蛋白尿患者： 1. GC 1008单次输注的安全性和耐受性 2. GC 1008单次输注后GC 1008的药代动力学 受试者：耐药FSGS患者-4个队列中的5例患者 程序（方法）：这是一项I期、开放标签和剂量递增研究，评估了GC 1008单次给药在难治性特发性FSGS患者中的安全性、耐受性和药代动力学特征。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: To determine in patients with treatment resistant idiopathic FSGS and nephrotic range proteinuria: 1. Safety and tolerability of single dose infusions of GC1008 2. Pharmacokinetics of GC1008 following single dose infusions of GC1008 Participants: Patients with resistant FSGS-5patients in 4 cohorts Procedures (methods): This is a phase I, open-label, and dose-escalation study assessing the safety, tolerability and pharmacokinetic profile of single doses of GC1008 in patients with treatment resistant idiopathic FSGS.