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

• Conditions: Prophylaxis of heart transplant rejection.; MedDRA version: 12.1Level: LLTClassification code 10050432Term: Prophylaxis against heart transplant rejection

• Registration Number: EUCTR2010-022941-72-AT
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-28
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

1. Age = 18 years.
2. Received a heart transplant at least 6 months and no longer than 6 years prior to
enrollment
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.
7. Subject's immunosuppressive regimen remained unchanged for a minimum of 6 weeks prior to enrollment.
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

Exclusion Criteria

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 treatment.
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 levels =3 times the upper value of the normal range of the investigational site.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified