Fibrosis in Renal Allografts (NCT00493194) | Clinical Trial Compass
UnknownPhase 4
Fibrosis in Renal Allografts
Belgium100 participantsStarted 2005-05
Plain-language summary
This prospective, randomized study, comparing sirolimus to cyclosporine in renal transplant recipients, has two major objectives:
1. -To determine the incidence and the degree of interstitialfibrosis and arteriosclerosis, as wel as the glomerular volume in protocol biopsies at 6 months in sirolimus-and in cyclosporine-treated renal allograft recipients, by means of quantitative computerized image analysis.
* To determine the prognostic implication of these morphologic changes.
2. To study the expression of genes, involved in inflammation and fibrosis, in protocol biopsies at 6 months in sirolimus-and cyclosporine-treated renal allograft recipients.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Recipients of a renal allograft, with a minimum age of 18 years.
✓. Male or female recipients. Women of child-bearing age must practice adequate contraception
✓. For renal allografts from living donors, at least one HLA-mismatch is required.
✓. Written informed consent, compliant with local regulations.
Exclusion criteria
✕. Recipients of a second or third renal allograft, with a past history of graft failure due to rejection.
✕. Recipients of a renal allograft from a haplotype-identical living donor or a non-heart beating donor.
✕. Cold ischemia time \> 24 hours
✕. Recipients of a kidney from donors ≥ 65 years of age
✕. Recipients of multiple organs.
✕. Pregnant women.
What they're measuring
1
The primary end-point of this study will be the cortical fractional interstitial fibrosis volume (V IntFib) in protocol biopsies at 6 months. The V IntFib will be determined on Sirius red stained slides by means of a computerized image analysis program,