A MULTICENTER, TWO ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY TO COMPARE RENAL FUNCTION IN STABLE HEART TRANSPLANT RECIPIENTS RECEIVING AN ADVAGRAF® BASED IMMUNOSUPPRESSIVE REGIMEN WITH OR WITHOUT EVEROLIMUS - ADVANTAGE

Astellas Pharma Europe Ltd.0 个研究点目标入组 336 人开始时间: 2011年3月1日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1. Age = 18 years.
•2. Received a heart transplant at least 6 months and no longer than 6 years prior to
•3. eGFR between 30-90ml/min estimated using the MDRD4 formula at time of
•enrollment.
•4. Female and male subjects agree to maintain highly effective birth control during the
•study and for 90 days after discontinuation of dosing with study drugs. A highly
•effective method of birth control is defined as those which result in a low failure rate
•(CPMP/ ICH/ 286/ 95 modified) of less than 1% per year when used consistently and
•correctly such as implants, injectables, combined oral contraceptives, some
•Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner.
•5. Capable of understanding the purpose and risks of the study, has been fully informed
•and has given written informed consent (signed Informed Consent Form (ICF) has
•been obtained).
•6. 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

•1. Previously received an organ transplant other than a heart.
•2. Acute rejection episode within 6 weeks prior to enrollment requiring treatment or a
•steroid resistant acute rejection episode within 12 weeks prior to enrollment requiring
•3. Evidence of malignant disease within the last 5 years other than Basal Cell Carcinoma
•or Squamous Cell Carcinoma of the skin.
•4. Pregnant woman or breast-feeding mother.
•5. Subject or donor known to be HIV positive.
•6. Known allergy or intolerance to tacrolimus, everolimus, macrolide antibiotics,
•steroids, additional concomitant immunosuppressive medication or to the excipients
•of the study medication.
•7. Any unstable medical condition that could interfere with the study objectives in the
•opinion of the Investigator.
•8. Currently participating in another interventional clinical trial, and/or has taken an
•investigational drug within 28 days prior to enrollment.
•9. Any form of substance abuse, psychiatric disorder or condition which, in the opinion
•of the Investigator, may complicate communication with the Investigator.
•10. Unlikely to comply with the visits scheduled in the protocol.
•11. Poor left ventricular function, defined as LVEF = 30%.
•12. Currently receiving treatment with everolimus.
•13. Elevated SGPT/ALT and/or SGOT/AST and/or total Bilirubin

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