Kidney transplant recipients Tacrolimus Everolimus Niertransplantatie patiënten
Conditions
Interventions
Conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression three months after kidney transplantation. At three months after transplantation patients will be randomized for
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Treatment with immunosuppressive therapy consisting of tacrolimus, corticosteroids and mycophenolate mofetil at 3 months after transplantation; 2. Patients who have given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Acute rejection episodes less than 4 weeks prior to randomization; 2. Proteinuria ≥ 1.0 g/day; 3. GFR ≤ 30 mL/min; 4. Recipient of multiple organ transplants; 5. Recipient of ABO incompatible allograft or a positive cross-match; 6. Patient who is human immunodeficiency virus (HIV) positive; 7. Patient who received an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor; 8. Patient with severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment that would prevent patient from potential exposure to everolimus, or with hypersensitivity to drugs similar to everolimus (e.g. macrolides); 9. Patient with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled; 10. Patient with white blood cell (WBC) count ¡Ü 2,000 /mm3 or with platelet count ≤ 50,000 /mm3; 11. Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy or other severe surgical complication in the opinion of the investigator; 12. Presence of intractable immunosuppressant complications or side effects; 13. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For this conversion study renal function is the primary endpoint. Mean MDRD clearances will be compared between tacrolimus and everolimus treated patients at month 12. Also changes in MDRD clearances within individual patients in the tacrolimus and everolimus treated patients between month 3 and 12 will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of acute rejection between month 3 and month 12; 2. Renal histology, including signs of calcineurin inhibitor related nephrotoxicity, at month 12; 3. Graft survival; 4. Adverse events; 5. Correlation between drug exposure parameter and incidence of rejection or toxicity after month 3. | — |
Contacts
Public ContactW. Weimar
's Gravendijkwal 230
Outcome results
None listed