Kidney transplant recipients MedDRA version: 18.0 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865
Conditions
Sponsors
Fujisawa Healthcare, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has been fully informed and has signed an IRB approved informed consent/authorization form and is willing and able to follow study procedures. 2. Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant. 3. Patient is age greater or equal to 12 years. 4. Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure. 5. Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization. Are the trial subjects under 18? yes Number of subjects for this age range: 2 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 658 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has previously received or is receiving an organ transplant other than a kidney. 2. Patient has received a kidney transplant from a non-heart beating donor. 3. Patient has received an ABO incompatible donor kidney. 4. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV). 5. 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. 6. Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or AL T (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site. 7. Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives. 8. Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant. 9. Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study. 10. Patient has a known hypersensitivity to tacrolimus, cyc1osporine, mycophenolate mofetil or corticosteroids. 11. Patient is pregnant or lactating. 12. Patient is unlikely to comply with the visits scheduled in the protocol. 13. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator. 14. Patient has received a kidney with a cold ischemia time of;::: 36 hours 15. Patient has received a kidney transplant from a cadaveric donor;::: 60 years of age 16. Patient received IVIG therapy prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy ofPrograf®/MMF and Neoral®/MMF in de novo kidney transplant recipients. To compare the safety and efficacy of Modified Release (MR) Tacrolimus/MMF and Neoral®/MMF in de novo kidney transplant recipients.;Secondary Objective: To compare the safety and efficacy of Modified Release (MR) Tacrolimus/MMF and Prograf®/MMF in de novo kidney transplant recipients.;Primary end point(s): Efficacy failure rate.;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of biopsy confirmed acute rejection (Banff Grade 2: I) • Requirement of anti -lymphocyte antibody therapy for treatment of rej ection • Severity of acute rejection • Patients experiencing multiple rejection episodes • Clinically treated acute rejection episodes • Treatment failure • Crossover for treatment failure • Renal function (by calculated creatinine clearance and serum creatinine) • patient and graft survival rates;Timepoint(s) of evaluation of this end point: 6 months 12 months 2 years 3 years Time to first acute rejection episode | — |
Countries
Brazil, Canada, United States
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.
Outcome results
None listed