EUCTR2008-003241-89-FR进行中（未招募）1 期
A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro™ Tablets, Once Daily, Compared to Prograf® Capsules, Twice Daily, in Combination with Mycophenolate Mofetil for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
ifeCycle Pharma A/S0 个研究点目标入组 540 人开始时间: 2010年10月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 540
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent.
- •2. Between the ages of 18 and 70 years, inclusive.
- •3. Patients must be receiving primary or secondary renal allograft from a deceased donor or non- human leukocyte antigen (HLA) identical living donor.
- •4. Patients must have no known contraindications to the administration of IL-2 receptor antagonist induction therapy, MMF, corticosteroids or tacrolimus.
- •5. Women of childbearing potential (WOCBP) should have a negative pregnancy test (serum or urine pregnancy test with a sensitivity of a least 25 mIU/mL) within 1 week prior to beginning therapy. WOCBP must be willing to agree to contraceptive practices as detailed in the Contraception Guidelines (Section 8.2.4).
- •6. Negative cross match test, and compatible (A, B, AB or O) blood type.
- •7. Able to swallow tablets and capsules.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Recipients of any non-renal transplant (solid organ or bone marrow) ever.
- •2. Panel reactive antibody (PRA) >30%.
- •3. Patients with any condition that may affect study drug absorption (e.g., gastrectomy or clinically significant diabetic gastroenteropathy).
- •4. Body mass index (BMI) <18 kg/m2 or > 40 kg/m2, calculated using the formula of BMI = mass/(height2).
- •5. History of alcohol abuse with less than 6 months of sobriety.
- •6. History of recreational drug abuse with less than 6 months of documented abstinence.
- •7. Screening 12-lead ECG demonstrating clinically relevant abnormalities (including QTc prolongation, reversible ischemia and clinically symptomatic congestive heart failure or documented ejection fraction of less than 45%).
- •8. WOCBP who are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test.
- •9. Patients with an oral temperature (prior to study drug dosing) of 38 ºC (100.4 ºF) or higher.
- •10. Patients with clinically significant active infections (for example, those requiring hospitalization, or as judged by the Investigator) including current, latent or prior tuberculosis infection.
- •11. Patients with known hereditary immunodeficiency.
- •12. Patients with malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised: cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ.
- •13. Patients who are receiving or expect to receive sirolimus, everolimus, azathioprine or cyclophosphamide within 3 months prior to enrollment.
- •14. Patients with evidence of clinically significant disease (e.g., cardiac, gastrointestinal or hepatic disorders) that places the patient at increased risk for participating in the study and/or will confound the result of the study.
- •15. Patients with reversible ischemia (history of untreated reversible ischemia on stress test).
- •16. Patients with clinically symptomatic congestive heart failure or documented ejection fraction of less than 45%.
- •17. Patients with significant chronic obstructive pulmonary disease, pulmonary restrictive disease or significant pulmonary hypertension.
- •18. Treatment with an investigational drug, device or regimen within 1 year preceding the first dose of study drug.
- •19. Patients who are unwilling to refrain from consumption of grapefruit or grapefruit containing juices for the duration of the study period.
- •20. Patients receiving concomitant drugs that may affect concentrations of tacrolimus in whole blood, as listed in Appendix 2.
- •21. Laboratory variables that are abnormal (outside laboratory reference range) and clinically relevant as judged by the Investigator.
- •22. Patients with positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab). Negative results for these serological tests must be documented within 12 months prior to randomization.
- •23. Patients who experienced graft loss within 1 year of transplant, due to acute rejection or due to BK nephropathy.
- •24. Patients having experienced focal segmental glomerulosclerosis (FSGS).
- •25. Donor with positive serological test result for HIV-1, HBV or HCV.
- •26. Donor with history of malignant disease (current or historical).
- •27. Centers for Disease Control and Prevention high-risk donor.
- •28. Patients with me
研究者
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