Transplantation
Conditions
Keywords
Tacrolimus, Kidney Transplantation
Brief summary
Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.
Detailed description
Multicenter, single-arm, open phase IIIb, conversion study where a Cyclosporine A-based immunosuppressive regimen is replaced by the administration of tacrolimus modified release formulation, MR4, once daily (morning dosing only) in stable renal transplant subjects. The initial recommended dose of MR4 is 0.1 mg/kg/day. Twenty-four weeks of treatment on MR4-based immunosuppressive regimen is considered to be an appropriate study duration in order to assess the response in subjects suffering from one or more known cyclosporine side effects, hypertrichosis/hirsutism, gingival hyperplasia, hyperlipidemia, arterial hypertension. Stable, adult kidney transplant recipients (≥ 12 months post transplant) who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled.
Interventions
DRUGtacrolimus
immunosuppression
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Serum creatinine \< 200 µmol/l (\< 2.3 mg/dl) at enrollment. * Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. * Capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent (signed Informed Consent has been obtained).
Exclusion criteria
* Previously received an organ transplant other than a kidney. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in creatinine clearance, calculated according to Cockcroft and Gault formula. | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall | Week 24 |
| Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol) | Week 24 |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland
Outcome results
None listed