ADVAgraf® Study Observing Renal FunctioN in Heart TransplAnt Graft REcipients

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10050432Term: Prophylaxis against heart transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Prophylaxis of heart transplant rejection.

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-21
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Age = 18 years.
2.Received a heart transplant at least 6 months and no longer than 8 years prior to starting study treatment.
3.Subjects who are otherwise stable heart transplant recipients with mild to moderate decline in renal function as evidenced by
•a baseline eGFR 30-60 ml/min estimated using the MDRD4 formula at the time of enrollment prior to starting study treatment t OR
•a baseline eGFR between 60-90 ml/min estimated using the MDRD4 formula prior to starting study treatment with at least a 10% decline in eGFR in the 12 months prior to enrolment.
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.Subject’s immunosuppressive regimen (combination of medicines i.e. the individual drugs used)* remained unchanged for a minimum of 12 weeks prior to enrollment. *minor changes to doses of individual drugs are acceptable if the Investigator regards the subject and the overall regimen as stable during this period.
7.Receiving a Prograf® or ciclosporin based immunosuppressive regimen.
8.Subject should be able to receive Advagraf, if clinically indicated , after the completion of the study period.

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 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Subject will be excluded from participating if any of the following apply:
1.Previously received an organ transplant other than a heart.
2.Acute rejection episode within 6 weeks prior to starting study treatment requiring treatment or a steroid resistant acute rejection episode requiring treatment within 12 weeks prior to starting study 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, macrolide antibiotics, steroids 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.Proteinuria >1g/24 hours.
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.
14.Subject with a tacrolimus trough level less than 6ng/ml at baseline.

Study & Design

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