Calcineurin-inhibitor Nephrotoxicity and Efficacy Study.
Completed
- Conditions
- De novo renal transplant recipients.
- Registration Number
- NL-OMON21129
- Brief Summary
J Am Soc Nephrol. 2006 Sep;17(9):2622-32. Epub 2006 Aug 9.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 126
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;
Exclusion Criteria
1. Patients who are receiving a simultaneous pancreas kidney transplant or a double kidney transplant;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To investigate which drug regimen is associated with the best graft structure and function at 6 and 12 months; <br /><br>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; <br /><br>3. Graft function will be assessed by measuring glomerular filtration rate (GFR) using 125I-iothalamate and protein excretion rate.
- Secondary Outcome Measures
Name Time Method 1. Patient and graft survival; <br /><br>2. Rejection episodes: number of (biopsy-proven) acute rejection episodes, their severity, histopathological pattern and time to first rejection episode;<br /><br>3. Side effect profile: blood pressure, cholesterol, fasting glucose, HbA1c, uric acid, need for supportive treatment, infectious complications, lymphoproliferative disorders;<br /><br>4. Calcineurin inhibition; <br /><br>5. Plasma levels of TGF-b; <br /><br>6. MPA-levels and IMPDH activity over time; <br /><br>7. mRNA expression of collagen in biopsies; <br /><br>8. Functional analysis of T lymphocytes. Assessment of the CMV-specific CD4+ T cell proliferation.