Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
研究概览
简要总结
The purpose of the study is to combine Urodilatin (ANP analogue), which will increase glomerular filtration rate (GFR), and mannitol, which will increase the rate of urinary flow and solute excretion. We intend to treat twenty consecutive allogeneic bone marrow transplant patients in a phase II study comparing results with historical controls.
We hypothesize that the incidence of renal dysfunction, ARF and thus mortality in allogeneic bone marrow transplantation can be significantly reduced by the use of protective agents Urodilatin and mannitol. We feel that this combination is best administered prior to and during the first two weeks of treatment when patients encounter immunosuppressive agents and the onset of early transplantation complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age 18-65 years
- •Presence of malignancy or hematological disease whose treatment will be allogeneic stem cell transplant and high-dose conditioning therapy.
- •Adequate baseline evaluation: adequate renal function (creatinine clearance > 60 ml/min); Adequate hepatic function (SGOT, SGPT, bilirubin and alkaline phosphatase < 1.5 times normal); adequate cardiac function (MUGA showing a left ventricular ejection at rest > 45%); adequate pulmonary function (DCLO > 60%).
排除标准
- •Known hypersensitivity to ANP or mannitol
- •Congestive heart failure
- •Previous bone marrow transplant
- •BP less than 90 mm systolic or less than 60 mm Hg diastolic
结局指标
主要结局
Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival
次要结局
- Patient will be followed at 3 month intervals for the first year and then yearly for life.