Long-term Follow-up of Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To compare between treatment groups, change in renal function as measured by 24 hour creatinine clearance and estimated GFR.
研究概览
简要总结
Allograft nephropathy is the most common cause of allograft failure following kidney transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may be one of the important progression factors.
"Spare the Nephron"(STN) is a unique study. Patients were randomized to either continue center-specific Calcinerium Inhibitor (CNI) therapy or have CNI replaced with sirolimus within the first six months after transplantation. Approximately 305 patients were enrolled in the study. More than 230 patients finished 2 years of follow-up. There was better patient and graft survival in those converted to sirolimus. There was also a 10% improvement in the kidney function of those who were converted. In this cohort, we wish to explore the durability of this improvement.
详细描述
In this extension study we will be extending our clinical observation of the STN patients from two to five years. It is expected that a Calcinerium Inhibitor (CNI) sparing regimen will be associated with better preservation of kidney function and fewer cardiovascular events.
STN is a prospective multi-center study that has completed enrollment of 305 first time recipients of kidney allografts from 27 centers. The enrollees were randomly assigned either to continue the center-specific CNI regimen (assigned at the time of transplantation) or were switched to replace the CNI with sirolimus therapy. Either CNI or sirolimus are being used in combination with CellCept therapy with or without the use of maintenance steroids, based on individual center preferences. Induction therapy was also center-specific.
In the present long-term follow-up study we will approach patients previously enrolled in the STN study and offer them the opportunity to enroll to be followed for another 3 years. There will be no changes in immunosuppression unless clinically indicated. The majority of the effort is standard care with every 6 month follow-up appointments.They will be required to be consented to participate in the three year extension study.
Research procedures:
The only inclusion criteria is willingness to sign the consent form for the extension study, after successful completion of the two year STN study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male or female post-transplant patients who were in the Spare-the-nephron study.
- •Patients capable of understanding the purpose and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- •Women of child bearing potential must not be pregnant or breast-feeding.
- •Women of child bearing age must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy or hysterectomy. Effective contraception must be used before beginning of study drug therapy, for duration of study and for 12 weeks following the completion of study.
- •Must pass the evaluation to sign informed consent form.
排除标准
- •Male or female post-transplant patients who were enrolled in the Spare-the-nephron study, however dropped out during the study period.
- •Inability to pass the Evaluation to Sign Consent.
结局指标
主要结局
To compare between treatment groups, change in renal function as measured by 24 hour creatinine clearance and estimated GFR.
时间窗: Every 6 months for 3 years.
次要结局
- Graft and patient survival.(Every 6 months for 3 years.)
研究者
Matthew R Weir
PI
University of Maryland, Baltimore