12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
研究概览
简要总结
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who had received a primary or secondary kidney transplant
- •Patients who were willing and from whom written informed consent was obtained
- •kidney allograft with a cold ischemia time (CIT) < 30 hours
- •negative pregnancy test prior to study enrollment
排除标准
- •-Multi-organ recipients
- •former Graft loss due to immunological reasons
- •Patients who received a kidney from a non-heart beating donor
- •A-B-0 incompatible transplants
- •a current Panel Reactive Antibody (PRA) level of > 20%
- •existing antibodies against the HLA-type of the receiving transplant
- •a known hypersensitivity/contraindication to any of the immunosuppressants
- •Use of other investigational drugs
- •Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 8 g/dL
- •significant mental illness
- •history of malignancy during the last five years
- •HIV positive
- •uncontrolled hypercholesterolemia or hypertriglyceridemia
- •drug or alcohol abuse
- •pregnant or breast feeding women
研究组 & 干预措施
TAC+MPA
干预措施: Enteric Coated Mycophenolate Sodium (EC-MPS) (Drug)
CycA+Certican
干预措施: Cyclosporin A (Drug)
TAC+MPA
干预措施: Tacrolimus (Drug)
TAC+MPA
干预措施: Mycophenolate mofetil (MMF) (Drug)
TAC+MPA
干预措施: Corticosteroids (Drug)
TAC+MPA
干预措施: Simulect (Drug)
TAC+Certican
干预措施: Everolimus (Drug)
TAC+Certican
干预措施: Tacrolimus (Drug)
TAC+Certican
干预措施: Corticosteroids (Drug)
TAC+Certican
干预措施: Simulect (Drug)
CycA+Certican
干预措施: Everolimus (Drug)
CycA+Certican
干预措施: Corticosteroids (Drug)
CycA+Certican
干预措施: Simulect (Drug)
结局指标
主要结局
Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
时间窗: One year post transplant
To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula: GFR = 6.7/Scr + BW/4 - Surea/2 - 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set
次要结局
- Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12(Month 12 post transplant)
- Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant(Month 12 post transplant)
- Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant(Month 12 post transplant)
- Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant(Month 12 post transplant)
- Percentage of Participants With Treatment Failure Endpoints at Month 12(Month 12 post transplant)
- Percent of Participants With Delayed Graft Function and Slow Graft Function(Post transplant to month 12)
- Percent of Participants With Delayed Graft Function by Day(Post transplant up to day 7)
- Percent of Participants With Viral Infections(Post transplant to month 12)
- Percent of Participants With Wound Healing Complications During Study(Post transplant until individual reporting)
- Duration of Wound Healing(Post transplant until individual reporting)