Prophylaxis of heart transplant rejection. MedDRA version: 12.1 Level: LLT Classification code 10050432 Term: Prophylaxis against heart transplant rejection
Conditions
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare two immunosuppressive therapy regimens with respect to their influence on estimated Glomerular Filtration Rate (eGFR) at 52 weeks after conversion to Advagraf using the MDRD 4 formula.;Secondary Objective: The secondary objective is to compare the safety and efficacy profiles of the two immunosuppressive therapy regimens with each other.;Primary end point(s): The Primary Variable is renal function assessed by eGFR at 52 weeks following conversion to Advagraf using the MDRD 4 formula. | — |
Countries
Austria, Czech Republic, Spain
Outcome results
None listed