A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 850
- 试验地点
- 101
- 主要终点
- Participant Survival
研究概览
简要总结
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.
详细描述
The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a long-term treatment in transplant recipients. Only patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of study medication were enrolled.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had already participated in the previous phase II pharmacokinetic or phase III studies with FK506E (MR4).
- •Patients capable of understanding the purpose and risks of the study, who had been fully informed and given written informed consent to participate in the study.
排除标准
- •Pregnant women or nursing mothers.
- •Women unwilling or unable to use adequate contraception during the study.
研究组 & 干预措施
1: FK506E (MR4)
Single open arm of FK506E (MR4). Since this was an extension study for many studies, generally the dose given at enrollment was to be continued. The investigator was permitted to adjust the subject's dose and modify the MR4 dose regimen as deemed necessary to minimize Adverse Events (AEs) and maintain effective immunosuppression. MR4 capsules were taken orally, once daily in the morning. MR4 capsules were to be swallowed with fluid (preferably water) on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. MR4 was supplied as 0.5 mg, 1 mg and 5 mg capsules in amber glass bottles or in blister packs.
干预措施: FK506E (Drug)
结局指标
主要结局
Participant Survival
时间窗: Up to 5.5 years (66 months (phase II) and 24 months (phase III)).
Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood's formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
Graft Survival
时间窗: Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).
Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood's formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
次要结局
- Number of Participants With Adverse Events(From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).)
- Biopsy-confirmed Acute Rejection (BCAR) Episodes(Up to 6 years.)
- Time to First BCAR Episode(Up to 1344 days (3.75 years).)