Steroid Withdrawal and Novo Donor-specific Anti-HLA Antibodies in Renal Transplant Patients: a Prospective, Randomized and Controlled Study in Parallel Groups
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 5
- 主要终点
- Cases of Kidney Transplant Patients With DSA
研究概览
简要总结
Steroids are one of the pillars of immunosuppression for kidney transplant patients but their use is associated with a high rate of complications. Withdrawal of steroids reduces some metabolic and cardiovascular complications, but it may increase the risk of acute rejection. However, little is known about whether steroid withdrawal is associated with the generation of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and clinical and histological data. The aim of this study is to compare the incidence of de novo anti-HLA DSA in stable kidney transplant patients after withdrawing the steroids 3 months after the transplantation as compared with patients who continue with steroids. The hypothesis is that steroid withdrawal will increase the presence of de novo anti-HLA DSA in stable kidney transplant patients
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
- •Male and female patients aged over 18 years with no immunological risk (PRA <25% and no DSA) who are receiving their first cadaveric or living kidney transplant.
- •Patients who, three months after the transplantation, are receiving tacrolimus in combination with mycophenolic acid (MPA) or mycophenolate mofetil (MMF) plus steroids, with stable plasma levels of tacrolimus.
- •No clinical or histological immunological dysfunction before randomization
- •No de novo anti-HLA DSA at the time of randomization.
- •Patients who wish to and are able to give written informed consent to participate in the study.
- •For women, agreeing to use efficient contraception during the study.
排除标准
- •Patients who receive a multiorgan transplant.
- •Retransplants.
- •Presence of DSA before the transplant or at the time of randomization.
- •Cold ischemia time >30 hours
- •Patients with serum creatinine >2 mg/dL or proteinuria >1g/day at the time of randomization
- •Prior episode of severe rejection (II-B-III in the Banff/13 classification) prior to randomization.
- •Presence of subclinical rejection on the protocol biopsy prior to randomization
- •Patients with BK-polyomavirus nephropathy at the time of randomization.
- •Patients with recurrent or de novo glomerulonephritis.
- •Patients who are being treated with immunosuppressive drugs other than those in the randomized clinical trial in question.
- •Patients who are positive for the human immunodeficiency virus (HIV) or those who have a severe systemic infection that, in the investigator's judgment, will require continued treatment.
- •Patients with any present or prior (during the previous 5 years) malignant disease, except basal or squamous cell carcinoma that has been excised.
研究组 & 干预措施
Steroids, tacrolimus and mycophenolate
Normal treatment arm
干预措施: Prednisone continuation (Drug)
Tacrolimus and mycophenolate
Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs
干预措施: Prednisone withdrawal (Drug)
结局指标
主要结局
Cases of Kidney Transplant Patients With DSA
时间窗: 24 months
Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months
次要结局
- Renal Function(24 months)
- Mean Score on the Protocol Biopsies in the Two Treatment Groups(24 months)
- Lipid Profile(24 months)
- Blood Pressure(24 months)
- Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups(At 24 months)
- Number of Participants With Acute Rejection Lesions(24 months)
- Incidence of Diabetes Mellitus(24 months)
- Patient Survival(24 months)
- Graft Survival(24 months)