EUCTR2007-005376-13-NL进行中（未招募）不适用
A MULTICENTER, FOUR ARM, RANDOMIZED, OPEN LABELCLINICAL STUDY INVESTIGATING OPTIMIZED DOSING IN APROGRAF®-/ ADVAGRAF®-BASED IMMUNOSUPPRESSIVEREGIMEN IN KIDNEY TRANSPLANT SUBJECTS.Protocol for Phase IIIb Study of Advagraf® (FK506E (MR4)) - Short Title: OSAKA Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- •Subject is eligible for the study if all of the following apply:
- •1. Age = 18 years.
- •2. End stage kidney disease and a suitable candidate for primary renal transplantation or
- •re-transplantation (unless the graft was lost from rejection within 12 months).
- •3. Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor
- •with compatible ABO blood type.
- •4. Female subject of childbearing potential must have a negative serum pregnancy test at
- •enrollment and must agree to maintain effective birth control during the study.
- •5. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent has been obtained).
- •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
- •Subject will be excluded from participation if any of the following apply:
- •1. Receiving or having previously received an organ transplant other than a kidney.
- •2. Cold ischemia time of the donor kidney > 30 hours.
- •3. Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
- •(withdrawn of support awaiting cardiac arrest).
- •4. Significant liver disease, defined as having continuously elevated SGPT/ALT and/or
- •SGOT/AST and/or total bilirubin levels = 2 times the upper value of the normal range
- •of the investigational site or is receiving a graft from a hepatitis C or B positive donor.
- •5. Requiring initial sequential or parallel therapy with immunosuppressive antibody
- •preparation(s).
- •6. Requiring ongoing dosing with a systemic immunosuppressive drug prior to
- •transplantation.
- •7. Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting,
- •active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- •8. Pregnant woman or breast-feeding mother.
- •9. Subject or donor known to be HIV positive.
- •10. Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids,
- •basiliximab or mycophenolate mofetil or any of the product excipients.
- •11. Diagnosis of new-onset malignancy prior to transplantation, with the exception of
- •basocellular or squamous cell carcinoma of the skin which had been treated
- •successfully.
- •12. Currently participating in another clinical trial, and/or has taken an investigational drug
- •within 28 days prior to enrollment.
- •13. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of
- •the investigator, may complicate communication with the investigator.
- •14. Unlikely to comply with the visits scheduled in the protocol.
研究者
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