NCT00270634已完成2 期
A Phase IIb, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 (Voclosporin) and Tacrolimus (Prograf®) in De Novo Renal Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Biopsy Proven Acute Rejection (BPAR)
研究概览
简要总结
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.
详细描述
Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After Transplant (NODAT). Voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection.
Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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.
- •Patients must be receiving a first cadaveric or living donor renal transplant.
- •Patients must be able to receive oral medication at time of randomization.
- •Females who are not 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 practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.
- •Able to give written informed consent prior to screening procedures.
- •Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator.
排除标准
- •Receiving a HLA (human leukocyte antigen)identical living related transplant.
- •Cold ischemic time > 24 hours.
- •Peak PRA (panel reactive antibodies) > 30%
- •Cadaveric donors who are over age 60, non-heart beating donors, or any cadaveric donors positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •Transplantation of multiple grafts (e.g. kidney and pancreas).
- •Systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against cytomegalovirus [CMV] and/or pneumocystis carinii pneumonia (PCP) infection will be permitted).
- •Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus. Known negative serology prior to study entry may be used.
- •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 electrodesiccation.
- •Requires prohibited medications or treatment during the study.
- •Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) ≥ 3x upper limit of normal (ULN) at time of transplantation.
- •White blood cell count ≤ 2.8 x 10^9/L.
- •Triglycerides ≥ 3x ULN.
- •Pregnant women or nursing mothers.
- •Has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to enrollment.
- •Previous exposure to voclosporin.
- •A history of active alcoholism or drug addiction within 1 year prior to study entry.
- •Weighs < 45 kg (99 lbs) or > 140 kg (308 lbs).
- •A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the investigator.
- •Allergy to iodine.
研究组 & 干预措施
Low Dose Voclosporin
Active Comparator
Low dose voclosporin
干预措施: Voclosporin (Drug)
Mid Dose Voclosporin
Active Comparator
Mid Dose Voclosporin
干预措施: Voclosporin (Drug)
High Dose Voclosporin
Active Comparator
High Dose Voclosporin
干预措施: Voclosporin (Drug)
Tacrolimus
Active Comparator
Standard Dose Tacrolimus
干预措施: tacrolimus (Drug)
结局指标
主要结局
Biopsy Proven Acute Rejection (BPAR)
时间窗: Six months
The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.
次要结局
- Graft Survival(Six months)
- Hypertension, Hyperlipidemia, or Hyperglycemia(Six months)
- To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR)(Six months)
- The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition(Six months)
- Patient Survival(Six months)
- A Composite of Biopsy-proven Chronic Rejection Graft Loss, Death, or Lost to Follow up.(Six months)
研究者
研究点 (1)
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