EUCTR2006-000937-37-DE进行中（未招募）不适用
A MULTICENTER, OPEN, SINGLE SEQUENCE CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF A TACROLIMUS MODIFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN STABLE KIDNEY TRANSPLANT PATIENTS CONVERTED FROM A PROGRAF BASED IMMUNOSUPPRESSIVE REGIME
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
- 125
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 enrolment.
- •3. Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrolment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.
- •4. Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of 12 weeks prior to enrolment.
- •5. Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to practice effective birth control during the study.
- •6. Clinically stable in the opinion of the investigator.
- •7. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent Form 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
- •1. Previously received an organ transplant other than a kidney.
- •2. Acute rejection episode within 12 weeks prior to enrolment, or an acute rejection episode within the 24 weeks prior to enrolment 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 allergy to the study drug or any of its components.
- •5. Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
- •6. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
- •7. Currently participating in another clinical trial and/or has taken an investigational drug within 28 days prior to enrolment.
- •8. Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrolment.
- •9. Breast-feeding mother.
- •10. HIV positive.
- •11. Unlikely to comply with the visits scheduled in the protocol.
- •12. Proteinuria > 2 g / 24 hrs.
- •13. Creatinine clearance calculated according to Cockcroft and Gault to be < 40 mL/min.
- •14. Patient has Creeping creatinine” (defined as an increase of 20 % over the 6 months prior to enrolment).
- •15. 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.
- •16. Patient is known to have FSGS or MPGN Type II as an underlying disease.
- •17. Liver cirrhosis.
研究者
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