De novo renal transplant recipients.
Conditions
Interventions
Before transplantation, patients will be randomized 1:1 to receive either a standard CsA-based or tacrolimus-based immunosuppressive regimen and either a twice daily (b.i.d.) or once daily (o.d.) dosi
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female or male, aged between 18 and 70 years; 2. Recipient of a kidney graft (first or second) from a cadaveric donor or living (non-HLA identical) donor; 3. The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are receiving a simultaneous pancreas kidney transplant or a double kidney transplant; 2. Patients who are receiving a third or fourth transplant; 3. Patients who have > 50 % (current or historic) panel reactive antibodies; 4. Female patients who are pregnant or unwilling to use adequate contraception during the study; 5. Patients on other investigational drugs; 6. Patients who are unable to take medication orally; 7. Patients with a life expectancy less than 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To investigate which drug regimen is associated with the best graft structure and function at 6 and 12 months; 2. Degree of inflammation and fibrosis in renal biopsies taken at 6 and 12 months after implantation Biopsies will be evaluated according to the Banff '97 Criteria for Renal Allograft Biopsy Interpretation (appendix) and morphometric analysis of the interstitial fibrous tissue will be performed using the digital image analysis technique available in our department; 3. Graft function will be assessed by measuring glomerular filtration rate (GFR) using 125I-iothalamate and protein excretion rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient and graft survival; 2. Rejection episodes: number of (biopsy-proven) acute rejection episodes, their severity, histopathological pattern and time to first rejection episode; 3. Side effect profile: blood pressure, cholesterol, fasting glucose, HbA1c, uric acid, need for supportive treatment, infectious complications, lymphoproliferative disorders; 4. Calcineurin inhibition; 5. Plasma levels of TGF-b; 6. MPA-levels and IMPDH activity over time; 7. mRNA expression of collagen in biopsies; 8. Functional analysis of T lymphocytes. Assessment of the CMV-specific CD4+ T cell proliferation. | — |
Contacts
Public ContactJ.W. Fijter, de
Leiden University Medical Center (LUMC), Department of Nephrology, C3-P22, P.O. Box 9600
Outcome results
None listed