Clinical Investigation for Safety and Efficacy, Patient Reported Outcomes of the Conversion to ONce-a-day Immunosuppression After Kidney Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 7
- 主要终点
- acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up
研究概览
简要总结
The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier.
详细描述
This is a 6-month, single-arm, multi-center, open-label, continuous cohort study. 160 subjects who had kidney transplantations at least 3 months earlier will participate in the study. All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at the age of 20 to 65 who had kidney transplantations at least 3 months ago.
- •Recipients of kidney transplantations from a deceased / cadaveric donor, non-heart beating cadaveric donor / organ donor after cardiac death, or non-blood related or blood related live donor.
- •Patients being treated with Tacrolimus or Extended Release Tacrolimus as the existing immunosuppressant maintenance therapy.
- •Able and willing to give informed consent to study participation, having signed the informed consent form according to appropriate procedures, and capable of participating in the study by making visits according to study plans.
排除标准
- •HIV, HBsAg, or anti-HCV test positive patients or having received kidney transplantations from an HIV, HBsAg, or anti-HCV test positive donor.
- •History of severe allergies or hypersensitivities to drugs used in the study or other drugs with a similar chemical structure requiring acute (within the past 4 weeks) or chronic treatment.
- •Having received other investigational product within 30 days prior to enrollment into this study.
- •Women of childbearing potential who plan to become pregnant, pregnant and/or lactating women, women who do not intend to use effective contraceptives.
- •Having uncontrolled diseases or medical conditions requiring continuous treatment.
- •History of alcohol or drug addiction within the past 3 months or incapable of appropriate communications due to reasons such as mental illness.
- •Absolute neutrophil count <1,500/mm3 or leukocyte count <2,500/mm3 or platelet count <75,000/mm3 at screening or severe metabolic disorders (including functional disorders).
- •Having experienced the following condition within the past 1 month:
- •Serum creatinine > 2.0 mg/dl more than twice.
- •24 hr urine protein≥750 mg/day
- •Diagnosed with or treated for a rejection reaction or an infection or hospitalized due to other medical reasons.
研究组 & 干预措施
advagraf
The same capacity advagaf + sirolimus
干预措施: advagrf (Drug)
结局指标
主要结局
acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up
时间窗: 6months
The primary objective of this study is to investigate the efficacy of Advagraf ® (Extended Release Tacrolimus) at 6 months after immunosuppressant conversion to the once daily therapy. The efficacy is defined as the incidence rate of composite endpoints of efficacy failure (acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up).
次要结局
- renal functions(6months)
- serious adverse events(6months)
- cardiovascular health(6months)
- NODAT(6months)
- hematology issue(6months)
研究者
Chang kwon oh
Professor,Department of surgery, Ajou University School of Medicine
Ajou University School of Medicine