EUCTR2004-000973-69-CZ进行中（未招募）不适用
A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus versus Cyclosporine when Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients.
Wyeth Research Division of Wyeth Pharmaceuticals Inc0 个研究点目标入组 500 人开始时间: 2005年12月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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. Age > 13 years and weight > 40 kg (age > 18 years in some regions per local regulations; see section H of this application form for requested subject age range in the region reviewing the application).
- •2. Subjects on dialysis with end-stage renal disease (ESRD) who will receive a primary renal allograft from a deceased donor, a living-unrelated donor, or a human leukocyte antigen (HLA)-mismatched living-related donor. An HLA mismatch is the number of HLA antigens that a donor has that a recipient does not share.
- •3. Subjects who receive a primary transplant before the initiation of maintenance dialysis, where the calculated creatinine clearance (CrCl) of the native kidney(s) must be <20 mL/min within 24 hours before transplantation from a deceased donor, a living-unrelated donor, or an HLA-mismatched living-related donor.
- •4. All female subjects at risk for pregnancy (ie are not surgically sterile or postmenopausal) must have a negative qualitative serum pregnancy test result before randomization, and must agree and commit to the use of a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study medication. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Any female subject who becomes pregnant during the treatment period must be discontinued from the on-therapy portion of the study.
- •5. Total white blood cell count greater than or equal to 4.0 x 10 9 /L(> 4,000 cells/mm3) and platelet count greater than or equal to 100.0 x 10 9/L (greater than or equal to 100,000 cells/mm3).
- •6. Fasting (8 to 12 hours) total cholesterol < 7.8 mmol/L (< 300 mg/dL) and fasting triglycerides < 3.95 mmol/L (< 350 mg/dL).
- •7. Signed and dated IRB / IEC approved informed consent form before screening and before any protocol-specified tests are performed that are not routinely conducted at the site. A parent or legal representative must provide written consent for subjects younger than the age of majority as defined by state and local laws. Subjects younger than the age of majority will also sign an assent form.
- •Are the trial subjects under 18? yes
- •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. Receipt of a kidney from a donor aged > 60 years; from a living donor aged > 65 years.
- •2. Receipt of a kidney from a donor aged 50 to 60 years and 2 of the following: terminal creatinine >1.5 mg/dL (132 micromol/L), death secondary to cerebral vascular accident, or known history of hypertension requiring medical treatment.
- •3. Receipt of a kidney from a living-related, HLA-identical donor.
- •4. Subjects who have had a previous solid organ transplant.
- •5. Suspected or confirmed active infection that has the potential to become systemic in the opinion of the primary investigator.
- •6. Evidence of known infiltrate, cavitation, or consolidation on chest radiograph that has not been repeated and interpreted as normal within the past 2 months.
- •7. Presence of unstable angina or ongoing use of maintenance therapy for a life-threatening arrhythmia.
- •8. Known or suspected malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin).
- •9. Use of any investigational drug within 4 weeks before randomization.
- •10. Prior or current use of sirolimus or any of its derivatives. Subjects with a sirolimus coated stent may participate.
- •11. Known hypersensitivity to CsA, basiliximab, MMF, or corticosteroid formulations.
- •12. Subjects receiving a kidney-pancreas or other multiple organ transplants.
- •13. Subjects who are receiving pediatric en bloc transplants, or dual adult kidney transplants.
- •14. Current use of ketoconazole (except topical), voriconazole, terfenadine, cisapride, astemizole, cimetidine, rosuvastatin, bosentan or pimozide. These agents must be discontinued prior to randomization.
- •15. Positive past medical history for documented human immunodeficiency virus (HIV) infection.
- •16. Within 6 months before randomization, subjects receiving a kidney from a deceased donor with the most recent HLA panel-reactive antibodies (PRA) > 20%. If a subject has received a transfusion of a blood product within 6 months before randomization, a PRA less than or equal to 20% must have been documented at least 3 weeks after the transfusion.
- •17. Receipt of a kidney where the total donor kidney ischemia time was > 30 hours.
- •18. Receipt of kidneys from nonheart-beating donors.
- •19. Subjects with a known positive B-cell or T-cell cross-match.
- •20. Subjects with ABO incompatibility with the allograft.
- •21. Subjects who have a BMI >30 kg/m 2.
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