A 12-month, Prospective, Randomized, Dual Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic® (Mycophenolic Acid) Loading Regimens in Combination With Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] or Simulect® (Basiliximab) Induction and Prograf® (Tacrolimus) in Early Corticosteroid Withdrawal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
研究概览
简要总结
This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients capable of understanding the purposes and risks of the study.
- •Patients who can give written informed consent, and who are willing and able to participate in the full course of the study.
- •Women of childbearing potential must have a negative serum pregnancy test within the last 48 hours prior to receiving study medication.
- •Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.
排除标准
- •Patients who are recipients of a multiple organ transplant or if the patient previously received and organ transplant.
- •Patients who are recipients of A-B-O incompatible transplants, all complement-dependent cytotoxicity (CDC) crossmatch positive transplants.
- •Sensitized patients [most recent anti-Human Leukocyte Antigens (HLA) Class I panel reactive antibody (PRA) ≥ 25% by a CDC-based assay].
- •Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
- •Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- •Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- •Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,500/mm3); and/or leucopoenia (< 2,500/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
- •Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
- •Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
- •Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication; diabetic patients with previously diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.
- •Patient is receiving chronic steroid therapy at the time of transplant.
- •Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
- •Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
- •Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
- •Inability to cooperate or communicate with the investigator.
研究组 & 干预措施
Myfortic preload
Initiation of mycophenolic acid (Myfortic) 2 weeks prior to transplantation (with Simulect induction at time of transplant)
干预措施: mycophenolic acid (Drug)
Myfortic standard
mycophenolic acid (Myfortic) at time of transplant with Thymoglobulin induction
干预措施: mycophenolic acid (Drug)
结局指标
主要结局
Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
时间窗: 3, 6 and 12 months post transplant
Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: As with humoral rejection, there are both acute \& chronic forms: The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections). Class IB: just like Class IA except there is more severe tubulitis. Class IIA: there is mild-to-moderate intimal arteritis. Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area. Class III: there is transmural (e.g. the full vessel wall thickness) arteritis.
次要结局
- Severity of Acute Rejection by Banff '97 Criteria(Severity 1 year post transplant)
- Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection(1 year)
- Difference in Renal Function(Difference at 1 month, 3 months, 6 months, 1 year)
- Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97(1 year)
研究者
Adele Rike-Shields
PharmD
University of Cincinnati