NL-OMON45886招募中2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.;See protocol for more details and other inclusion criteria.
排除标准
- •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).;See protocol for more details and other exclusion criteria.
研究者
相似试验
进行中（未招募）
1 期
CCFZ533X2201 PoC study in de novo renal transplantatioacute rejection of renal transplant in de novo adult renal transplant patientsMedDRA version: 19.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865EUCTR2015-000925-36-NLovartis Pharma Services AG306
进行中（未招募）
1 期
CCFZ533X2201 PoC study in de novo renal transplantatioacute rejection of renal transplant in de novo adult renal transplant patientsMedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865EUCTR2015-000925-36-DEovartis Pharma Services AG59
进行中（未招募）
1 期
CCFZ533X2201 PoC study in de novo renal transplantatioEUCTR2015-000925-36-ESovartis Farmacéutica S.A.306
进行中（未招募）
1 期
Study to evaluate renal function of everolimus plus tacrolimus in liver transplant patientsliver transplantationMedDRA version: 20.0Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865EUCTR2011-003118-17-DEovartis Pharma GmbH
进行中（未招募）
1 期
Study of the safety and efficacy of the drug CFZ533 (Iscalimab) in subjects who have received a liver transplantEUCTR2018-001836-24-FRovartis Pharma AG128