Prospective, Multicenter, Randomized, Open-label, Phase 2, Lasting 12 Weeks, Evaluating the Pharmacodynamics, Efficacy and Safety of Basiliximab in de Novo Adult Renal Transplant Patients at Low Risk Receiving Either a Cumulative Dose of Basiliximab of 40 or 80 mg in Combination With Cyclosporine Microemulsion, or a Cumulative Dose of 80 mg of Basiliximab Without Calcineurin Inhibitor, With Additional Follow-up of 12 Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Saturation Rate of CD25 Antigen Saturation by Basiliximab
研究概览
简要总结
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®.
It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving a primary renal graft from a deceased or living, related or unrelated donor and who require basiliximab induction therapy
- •Cold ischemia time < 30 hours
- •Exclusion (Non inclusion) criteria:
- •Patients undergoing multi-organ transplantation, including both kidneys, or who have previously undergone organ transplantation, including renal transplantation
- •Patients receiving a graft from a non-heart-beating donor
- •A-B-O incompatible graft or positive T cell crossmatch
- •Patients receiving a graft from an expanded criteria donor according to the UNOS definition (donor older than 60 years or donor aged between 50 and 60 years and presence of at least 2 of the following factors: hypertension, serum creatinine concentration ≥ 132 µmol/mL, cardiovascular cause of death)
- •Positive anti-HLA antibodies (Luminex) prior to transplantation
- •Patients whose original renal disease was primary focal and segmental hyalinosis or was related to atypical hemolytic uremic syndrome
- •EBV-negative patients receiving a graft from an EBV-positive donor (EBV D+R-)
- •Other protocol-defined inclusion/exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Simulect 80mg + Certican + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
干预措施: Certican® (Drug)
Simulect 40mg + Neoral + Myfortic + steroids
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
干预措施: Simulect® (Drug)
Simulect 40mg + Neoral + Myfortic + steroids
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
干预措施: Neoral® (Drug)
Simulect 40mg + Neoral + Myfortic + steroids
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
干预措施: Myfortic® (Drug)
Simulect 40mg + Neoral + Myfortic + steroids
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
干预措施: Corticosteroids (Drug)
Simulect 80mg + Neoral + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
干预措施: Simulect® (Drug)
Simulect 80mg + Neoral + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
干预措施: Neoral® (Drug)
Simulect 80mg + Neoral + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
干预措施: Myfortic® (Drug)
Simulect 80mg + Neoral + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
干预措施: Corticosteroids (Drug)
Simulect 80mg + Certican + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
干预措施: Simulect® (Drug)
Simulect 80mg + Certican + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
干预措施: Myfortic® (Drug)
Simulect 80mg + Certican + Myfortic + steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Saturation Rate of CD25 Antigen Saturation by Basiliximab
时间窗: Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation
CD25 saturation is the percentage of T cells expressing CD25
Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84
时间窗: Day 84 (Week 12) after transplantation
CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.
次要结局
- AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84(Day 84 (Week 12) post-transplantation)
- Percentage of T-cells That Bind Basiliximab to CD25 Receptors(Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation)
- Percentage of Participants With of Treatment Failures(Day 84 (Week 12), Week 24)
- Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24(Day 8, Week 24)
- Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)(Day 84 (Week 12), Week 24 post-transplantation)
- Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity(Day 84 (Week 12), Week 24 post-transplantation)
- Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells(Day 0, Day 6, Day 42, Day 84 (Week 12))