Standard induction therapy vs. no induction in low immunological risk renal transplant recipients: a single center, prospective, randomized, open-label, controlled trials.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of biopsy proven acute rejection within 3 months following transplant
研究概览
简要总结
End Stage Renal Disease is common in our country, with the need for renal replacement therapy (RRT) either in the form of dialysis or kidney transplantation. In patients undergoing renal transplantation, immunosuppressive therapy is given as induction therapy and maintenance therapy. According to the KDIGO guidelines, patients at low immunological risk for acute rejection receive standard induction therapy. However, recent scientific research has shown that induction therapy in low immunological risk renal transplant recipients does not confer significant advantage in acute rejection rates and long term patient or graft survival. It potentially increases the risk for infections and overall cost of the treatment. We are conducting this study to find out if renal transplantation without induction immunosuppressive therapy will affect the short term and long term outcomes in patients at low immunological risk for acute rejection.
We aim to conduct a prospective, randomized controlled trial to compare the outcomes of no induction therapy vs. standard induction immunosuppresion, in low immunological risk renal transplant recipients, on standard tacrolimus, mycophenolate mofetil and corticosteroid based triple maintenance immunosuppresion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give consent for participation in the study Low immunological risk: Primary (first) renal transplant Living kidney donor 3 or less Human Leukocyte Antigen mismatch (HLA A, B, DR matching scheme) Donor Specific Antibodies (DSAs) less than 1000 Mean Fluorescent Intensity (MFI) Negative CDC and Flow cytometry crossmatch.
排除标准
- •Patients refusing consent for participation in the study Contraindication to Basiliximab or rATG administration High immunological risk.
结局指标
主要结局
Incidence of biopsy proven acute rejection within 3 months following transplant
时间窗: 3 months following transplant
次要结局
- Delayed graft function(Need of at least one dialysis treatment within the first week post transplant)
- Length of first hospital stay(From the date of surgery to the date of discharge)
- Serum creatinine during post operative hospital stay, at 1 month, 2 months and 3 months post transplant.(Till 3 months)
- Incidence of infectious complications(Within 3 months)
- Incidence of new onset post transplant diabetes mellitus (PTDM)(Within 3 months)
- Patient and graft survival at 3 months post transplant(3 months)
研究者
Dr Ashish Limbani
Post Graduate Institute of Medical Education and Research, Chandigarh.