Kidney Transplantation
Conditions
Keywords
Organ Transplantation, Tacrolimus, Prograf, FK506MR
Brief summary
To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients
Interventions
DRUGPrograf
oral
DRUGMR4
oral
Sponsors
Astellas Pharma Korea, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure * Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment
Exclusion criteria
* Patient has previously received an organ transplant other than a kidney * Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor * Patients has received an ABO incompatible donor kidney * Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV) * Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully * Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site * Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives * Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant) * Patient has a known hypersensitivity to tacrolimus * Patient is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute rejection within 24 weeks (6 months) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1) | at 6 months |
| Time to first acute rejection episode | for 6 months |
| 6 month patient and graft survival rate | at 6 months |
| Severity of acute rejection | 6 months |
| Adverse events, laboratory parameters and vital signs | Throughout trial |
Countries
South Korea
Outcome results
None listed