Kidney Transplant Patients
Conditions
Keywords
RECORD study
Brief summary
This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.
Interventions
DRUGA) TEST
1. Extended Release Tacrolimus (Advagraf®) ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. 2. Sirolimus (Rapamune®): After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.
DRUGB) CONTROL
1. Extended Release Tacrolimus (Advagraf®) : Same as above. 2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged over 20 years * Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator * Patients has given written informed consent * Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.) * Patients has received an ABO compatible donor kidney. * Complement-dependent Cytotoxic Crossmatch: CDC) result: negative * Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization
Exclusion criteria
* Patient has previously received an organ transplant other than a kidney. * Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil. * Desensitization * HLA-identical * Heart Disease; Heart failure (symptom, EF \<45%) * Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease * Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable * malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma) * Patient has received a kidney transplant from non-heart beating donor * Cold ischemic time \> 30hrs * Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site * (ANC)\<1,500/mm3, (WBC)\<2,500/ mm3, (PLT)\<100,000/ mm3 * ATG: Anti-thymocyte globulin induction * Medical condition that could interfere with the study objectives. * Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment. * Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment. * Patient who is judged not to be adequate by the investigator owing to other reasons * Patient is pregnant or lactating. * Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure rate in effectiveness of up to 12 months after kidney transplant | 12 months after kidney transplant | 1. Biopsy confirmed acute rejection 2. Subjects and graft survival 3. Glomerular filtration rate (GFR) 4. 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl. |
Countries
South Korea
Outcome results
None listed