EUCTR2010-019639-37-CZActive, not recruitingNot Applicable
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
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Astellas Pharma Europe Ltd.
- Enrollment
- 772
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 579
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 193
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.
Investigators
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