Stable, adult kidney transplant recipients (at least 12 months post transplant) who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled. MedDRA version: 8.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Sponsors
Astellas Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Kidney transplant at least 12 months prior to enrollment. 3. Received a CyA-based immunosuppressive regimen since last transplantation. The dose of CyA has remained unchanged during the last four weeks prior to enrollment. 4. Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks prior to enrollment. 5. Experienced at least one of the following CyA-related adverse events at enrollment: a) Gingival hyperplasia where, in the opinion of the investigator, therapeutical intervention is required. b) Hypertrichosis/hirsutism where, in the opinion of the investigator, therapeutical intervention is required. c) Arterial hypertension (with the exception of known pre-transplant malignant nephrosclerosis) stages I-III (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90mmHg) despite treatment with at least one anti-hypertensive medication. The anti-hypertensive medication(s) has been prescribed at least 4 weeks prior to enrollment. d) Hyperlipidemia defined as total cholesterol higher than 220 mg/dl despite treatment with lipid-lowering medication(s) requires therapeutical intervention. The lipid-lowering medication(s) has been prescribed at least four weeks prior to enrollment. 6. Serum creatinine =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 kidney. 2. Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection episode within the 24 weeks prior to enrollment that required anti-lymphocyte antibody therapy. 3. Diagnosis of new-onset malignancy after transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. 4. Known to have FSGS or MPGN Type II as an underlying disease. 5. Proteinuria > 2 g / 24 hrs. 6. “Creeping creatinine” (defined as an increase of 20% within the 6 months prior to enrollment and at Baseline). 7. 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. 8. Liver cirrhosis. 9. Pregnant woman or breast-feeding mother. 10. HIV positive. 11. Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, additional concomitant immunosuppressive medication or to the excipients of the study medication. 12. Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator. 13. Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment. 14. Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment. 15. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator. 16. Unlikely to comply with the visits scheduled in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to assess the changes in kidney function in kidney transplant subjects converted from a CyA-based immunosuppressive regimen to a tacrolimus modified release, FK506E (MR4), based immunosuppressive regimen.;Secondary Objective: The secondary objective is to assess the safety and the efficacy of a MR4-based immunosuppressive regimen in kidney transplant subjects converted from a CyA-based immunosuppressive regimen experiencing CyA-related side effects.;Primary end point(s): Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) for each specific CyA-related side-effect group (hypertrichosis/hirsutism, gingival hyperplasia, hyperlipidemia, arterial hypertension). | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Portugal, Spain, Sweden
Outcome results
None listed