A Phase III, Randomized, Multicentre, Open-Label, Concentration-Controlled, Safety and Efficacy Study of Voclosporin and Tacrolimus in Renal Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.
详细描述
This will be a phase III, randomized, multicentre, open-label, concentration-controlled study in subjects undergoing a first or second renal transplant, with induction immunosuppression with an IL-2 receptor antibody (basiliximab), mycophenolate mofetil and steroids.
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Males and females aged 18-65 years inclusive at the time of screening.
- •Recipients of a first or second deceased donor or living donor renal transplant.
排除标准
- •Subjects presently receiving immunosuppression for a previously failed transplant.
- •Females who are pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication.
- •Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are not practicing a highly effective method of birth control.
- •Subjects receiving a HLA identical living related transplant.
- •Subjects wth a positive T-cell lymphocytotoxic cross match, or positive flow T and B cell cross match.
- •Subjects undergoing primary transplant with a current PRA (or CPRA) ≥ 25%.
- •Subjects who experienced graft loss within 1 year of transplant.
- •Subjects receiving a kidney from a ABO incompatible donor.
- •Subjects receiving a kidney from a deceased donor positive for HIV, HBV, HCV or tuberculosis.
- •Subjects receiving a a kidney from a non-heart beating donor.
- •Subjects receiving paired (en bloc or paired) kidney transplants.
- •Transplantation of multiple grafts (e.g. kidney and pancreas).
- •Subjects receiving a kidney with a cold ischemia time > 30 hours.
- •Subjects receiving any transplanted organ other than a kidney.
- •Recipients of a bone marrow or stem cell transplant.
- •Any systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against CMV and/or PCP infection will be permitted).
- •Subjects with positive results of the following serological tests: HIV I Ab, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and the anti-hepatitis C virus antibody (HCV Ab). Negative results for these serological tests must be documented within 12 months prior to randomization.
- •Subjects with active tuberculosis (Tb) requiring treatment within the last 3 years. Subjects with a known positive purified protein derivative (PPD) test are not eligible unless they have completed treatment for latent Tb and have a negative chest X-ray at time of enrollment. PPD testing must have been done within the last 12 months, and a positive result is defined as ≥ 10 mm induration, a Heaf score of >1 in non-Bacille Calmette-Guérin (BCG) immunized subjects, or >2 in BCG immunized subjects.
- •Subjects with a current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodessication.
研究组 & 干预措施
Tacrolimus
Tacrolimus
干预措施: tacrolimus (Drug)
Voclosporin
Voclosporin
干预措施: voclosporin (Drug)
结局指标
主要结局
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
时间窗: 1 Year post-Transplant
FDA Efficacy Failure is biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist) where subjects who experience death, graft loss (return to dialysis for \>30 days, allograft nephrectomy or re-transplantation), or lost to follow-up are included in the analysis as treatment failures. EMA Efficacy Failure includes any subject experiencing any of the following: biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist), death, graft loss or graft dysfunction (Cockcroft-Gault CrCl \< 40 mL/min).
次要结局
未报告次要终点