Kidney Transplantation
Conditions
Keywords
Tacrolimus, Kidney transplantation
Brief summary
The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
Interventions
DRUGTacrolimus
Oral
Sponsors
Astellas Pharma Korea, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients received a kidney transplant at least 12 months before enrollment. * Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL. * Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine. * Serum creatinine \< 2.3 mg/dl at enrollment * Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial. * Patients considered clinically stable
Exclusion criteria
* Patients who have previously received an organ transplant other than a kidney. * Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment. * Patients newly diagnosed malignant tumors after organ transplant, but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted. * Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN). * Proteinuria \> 2 g/24 hrs. * Patients who have Creeping creatinine (a 20% increase in their creatinine for six months before their enrollment). * Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center. * Patients who have liver cirrhosis. * Patients who are pregnant or breastfeeding. * Patients who had been HIV-positive. * Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants. * Patients who have an unstable medical condition that may affect the evaluation of the study's objectives. * Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment. * Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment. * Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in GFR | Baseline and Week 24 | GFR: glomerular filtration rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Triglycerides | Baseline and Week 24 | — |
| Change from baseline in LDL | Baseline and Week 24 | LDL: low density lipoprotein cholesterol |
| Change from baseline in HDL | Baseline and Week 24 | HDL: high density lipoprotein cholesterol |
| Change from baseline in the number of antihyperlipidemic drugs | Baseline and Week 24 | — |
| Change from baseline in blood pressure | Baseline and Week 24 | — |
| Change from baseline in the number of antihypertensive drugs | Baseline and Week 24 | — |
| Change from baseline in total cholesterol | Baseline and Week 24 | — |
| Change from baseline in number of participants who have had gingival hypertrophy | Baseline and Week 24 | Investigator's judgment |
| Overall incidence rate of adverse events | up to Week 24 | — |
| Proportion of participants with patient survival | up to Week 24 | — |
| Proportion of participants with organ survival | up to Week 24 | — |
| Acute rejection rate confirmed by biopsy | up to Week 24 | — |
| Ratio of mean dose of cyclosporine to tacrolimus | up to Week 24 | — |
| Change from baseline in number of participants who have had hirsutism | Baseline and Week 24 | Investigator's judgment |
Countries
South Korea
Outcome results
None listed