Stable, adult kidney transplant recipients (= 12 months post transplant) who are currently treated with Prograf. MedDRA version: 7.0 Level: LLT Classification code 10024716
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 enrolment. 3. Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrolment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL. 4. Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of 12 weeks prior to enrolment. 5. Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to practice effective birth control during the study. 6. Clinically stable in the opinion of the investigator. 7. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent Form 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
Exclusion criteria: 1. Previously received an organ transplant other than a kidney. 2. Acute rejection episode within 12 weeks prior to enrolment, or an acute rejection episode within the 24 weeks prior to enrolment 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 allergy to the study drug or any of its components. 5. Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator. 6. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator. 7. Currently participating in another clinical trial and/or has taken an investigational drug within 28 days prior to enrolment. 8. Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrolment. 9. Breast-feeding mother. 10. HIV positive. 11. Unlikely to comply with the visits scheduled in the protocol. 12. Proteinuria > 2 g / 24 hrs. 13. Creatinine clearance calculated according to Cockcroft and Gault to be < 40 mL/min. 14. Patient has “Creeping creatinine” (defined as an increase of 20 % over the 6 months prior to enrolment). 15. 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. 16. Patient is known to have FSGS or MPGN Type II as an underlying disease. 17. Liver cirrhosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of a tacrolimus modified release, MR4, based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg : mg) basis from a Prograf based immunosuppressive regimen. Non-inferiority for creatinine clearance will be assessed.;Secondary Objective: To assess the safety and efficacy of a tacrolimus modified release, MR4, based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg : mg) basis from a Prograf based immunosuppressive regimen. ;Primary end point(s): Change in creatinine clearance, calculated according to Cockcroft and Gault, between Prograf and MR4 | — |
Countries
Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed