A MULTICENTER, SINGLE-ARM, OPEN, CONVERSION STUDY FROM A CYCLOSPORINE (CyA) BASED IMMUNOSUPPRESSIVE REGIMEN TO A TACROLIMUS MODFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN KIDNEY TRANSPLANT SUBJECTS - CONCERTO

Astellas Pharma Europe Ltd0 个研究点目标入组 380 人开始时间: 2007年1月26日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Astellas Pharma Europe Ltd
入组人数: 380

研究概览入排标准研究者记录与标识符相似试验

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 = 18 years.
•2. Kidney transplant at least 12 months prior to enrollment.
•3. Received a CyA-based immunosuppressive regimen since last transplantation. The dose of CyA has remained unchanged during the last four weeks prior to enrollment.
•4. Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks prior to enrollment.
•5. Experienced at least one of the following CyA-related adverse events at enrollment:
•a) Gingival hyperplasia where, in the opinion of the investigator, therapeutical intervention is required.
•b) Hypertrichosis/hirsutism where, in the opinion of the investigator, therapeutical intervention is required.
•c) Arterial hypertension (with the exception of known pre-transplant malignant nephrosclerosis) stages I-III (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90mmHg) despite treatment with at least one anti-hypertensive medication. The anti-hypertensive medication(s) has been prescribed at least 4 weeks prior to enrollment.
•d) Hyperlipidemia defined as total cholesterol higher than 220 mg/dl despite treatment with lipid-lowering medication(s) requires therapeutical intervention. The lipid-lowering medication(s) has been prescribed at least four weeks prior to enrollment.
•6. Serum creatinine < 200 µmol/l (< 2.3 mg/dl) at enrollment.
•7. 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.
•8. Capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent (signed Informed Consent has been obtained).
•9. Clinically stable in the opinion of the investigator.
•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. Previously received an organ transplant other than a kidney.
•2. Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection episode within the 24 weeks prior to enrollment that required anti-lymphocyte antibody therapy.
•3. Diagnosis of new-onset malignancy after transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully.
•4. Known to have FSGS or MPGN Type II as an underlying disease.
•5. Proteinuria > 2 g / 24 hrs.
•6. Creeping creatinine” (defined as an increase of 20% within the 6 months prior to enrollment and at Baseline).
•7. 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.
•8. Liver cirrhosis.
•9. Pregnant woman or breast-feeding mother.
•10. HIV positive.
•11. Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, additional concomitant immunosuppressive medication or to the excipients of the study medication.
•12. Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
•13. Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment.
•14. Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
•15. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
•16. Unlikely to comply with the visits scheduled in the protocol.

研究者

发起方

Astellas Pharma Europe Ltd

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