A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acute rejection
研究概览
简要总结
The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.
详细描述
The use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. However, post-operative steroids are also associated with frequent post-operative and long term complications. There have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.
With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. We hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension.
Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. Those remaining on steroids will be discharged on prednisone 5 mg daily. Those in whom steroids are eliminated will be off prednisone by discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients undergoing a single renal transplant from deceased or living donor
- •Adults 18 years and older
- •First or second renal transplant
- •Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
- •Women of child bearing age should have a negative serum pregnancy test
排除标准
- •Greater than 2 renal transplants
- •Age < 18 years
- •Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
- •Cold ischemia time > 30 hours
- •History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
- •HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
- •Loss of previous transplant in < 1 year
- •History of non-compliance
- •Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
- •Multiple organ transplant
- •History of chronic steroid use except for inhaled steroids for asthma
- •Pregnant or lactating females
- •Women of childbearing potential not willing to use a reliable form of contraception.
- •Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
- •Known sensitivity to study drugs or class of study drugs
- •Use of any investigational agent in the last 30 days
研究组 & 干预措施
2
Subjects will be off steroids at the time of discharge
干预措施: prednisone (Drug)
结局指标
主要结局
Acute rejection
时间窗: 6 months
Patient and graft survival
时间窗: 6 months
Incidence of infection
时间窗: one year
次要结局
- Quality of life (health survey)(one year)
- Incidence of post-transplant diabetes(one year)
- Incidence of osteopenia/osteoporosis at baseline and one year(one year)
- Renal function(one year)