NCT00154232已完成4 期
A 3 Month, Multicenter, Open-label Study to Evaluate the Impact of the Immunosuppressive Combination of Enteric-Coated Mycophenolate Sodium (EC- MPS), Basiliximab and Cyclosporine for Microemulsion With C2 Monitoring, on Efficacy and Safety Outcomes in de Novo Kidney Transplant Recipients at Potential High Risk of DGF.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Incidence of first episodes of BPAR at month 3 post transplant
研究概览
简要总结
The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old
- •Patients receiving a primary or secondary cadaveric or living donor kidney
- •Patients who have given written informed consent for study participation
- •Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice birth control for the duration of the study and at least for four months following the last dose of basiliximab.
排除标准
- •Recipient of multi-organ transplants or previously transplanted organs other than kidney
- •Recipient of dual kidney transplants
- •Recipient of a transplanted kidney from a Non-Heart Beating Donor (NHBD)
- •Recipient of a HLA identical living-donor kidney
- •Patients with a PRA level (past or current level) greater than 20%
- •Patients anticipated by investigators to require induction therapy with OKT3, ATGAM, or Thymoglobulin for any reason
- •Patients with any medical condition which, in the opinion of the investigator, would preclude the patient from participating in the study
- •Cold ischemia time larger than 36 hours.
- •Patients who have received an investigational drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
- •Female transplant candidates who are pregnant, lactating, or of childbearing potential and not willing to practice an acceptable method of contraception
- •Patients with a known hypersensitivity to cyclosporine
- •Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
- •Known HIV positive antibody status
- •Evidence of any clinically relevant (per investigator determination) active infection
- •Patients unable to participate in the study for the full 3-month study period
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Incidence of first episodes of BPAR at month 3 post transplant
次要结局
- when the patient begins dialysis treatments without
- Incidence of graft loss or, synonymously, graft failure)
- The allograft will defined as lost (or: to have failed)
- subsequent graft recovery.
- Incidence of patients death at month 3 post transplant.
- The time of graft failure will be defined as the time of start of dialysis, or time of nephrectomy, whatever occurs first.
- Number of myfortic dose adjustments/discontinuations
研究者
相似试验
招募中
3 期
Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)Esophageal Squamous Cell CarcinomaNCT04807673Tianjin Medical University Cancer Institute and Hospital342
已完成
3 期
Belimumab in Remission of VASculitisVasculitisNCT01663623Human Genome Sciences Inc., a GSK Company106
已完成
3 期
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and CarboplatinLung Cancer - Non Small Cell SquamousNCT01285609Bristol-Myers Squibb1,289
已完成
4 期
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant RecipientsDe Novo Kidney Transplant RecipientsNCT00312143Novartis35
终止
3 期
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China ExtensionProstatic NeoplasmsNCT04907227Merck Sharp & Dohme LLC81