NCT00902980已完成不适用
Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 主要终点
- Change in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR)
研究概览
简要总结
This is a multicentre, observational, non-interventional, retrospective analysis by chart review.
详细描述
This study will compare differences in patient and graft related outcomes in renal transplant recipients followed in regional transplant centers versus satellite clinics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patient is at least 18 months post transplant
- •Patient had the current transplant during the period 1 July 1997 to no less than 18 months prior to chart review
- •Patient is currently on tacrolimus/MMF or AZA - or cyclosporine/MMF or AZA based immunosuppressive therapy
- •Patient is not a recipient of dual kidney or multi -organ transplant
- •Patient has a functioning graft (i.e. patient does not require dialysis)
- •Patient is recipient of a renal transplant including living or cadaveric, related or non-related, or pediatric en bloc kidneys, but excluding kidney-pancreas transplant recipients
- •Patient received the current transplant at one of six identified regional transplant centers
- •Patient is currently followed in a regional or satellite community based nephrology clinic
排除标准
- 未提供
结局指标
主要结局
Change in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR)
时间窗: 6, 12 and 18 months
次要结局
- Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia(6, 12 and 18 months)
- Comparison of patients on cyclosporine-vs. tacrolimus-based immunoprophylaxis as well as community-based vs. regional transplant nephrology clinics in both incidence of toxicities and related clinical interventions(6, 12 and 18 months)
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