A MULTICENTER, TWO ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY INVESTIGATING RENAL FUNCTION IN AN ADVAGRAF-BASED IMMUNOSUPPRESSIVE REGIMEN WITH OR WITHOUT SIROLIMUS IN KIDNEY TRANSPLANT SUBJECTS. - ADHERE

• Conditions: Prophylaxis of rejection in kidney allograft recipients (by immunosuppression); MedDRA version: 12.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejection

• Registration Number: EUCTR2010-019639-37-HU
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 772

Inclusion Criteria

1. Age = 18 years.
2. End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months).
3. Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen identical) donor with compatible ABO blood type.
4. Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment.
5. 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.
6. Capable of understanding the purpose and risks of the study, fully informed and having given written informed consent (signed Informed Consent 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

Exclusion Criteria

1. Receiving or having previously received an organ transplant other than a kidney.
2. Cold ischemia time of the donor kidney > 30 hours.
3. Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest).
4. Panel Reactive Antibody >20%.
5. Significant liver disease, defined as having continuously 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 or is receiving a graft from a hepatitis C or B positive donor.
6. Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
7. Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy).
8. Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
9. Pregnant woman or breast-feeding mother.
10. Subject or donor known to be HIV positive.
11. Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine.
12. Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers.
13. Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
14. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator.
15. Unlikely to comply with the visits scheduled in the protocol.

Study & Design

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