Overview

Fibrosis in Renal Allografts

Status:
Unknown status
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Antwerp
Collaborators:
Hoffmann-La Roche
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Cyclosporine
Cyclosporins
Daclizumab
Everolimus
Sirolimus
Criteria
Inclusion Criteria:

1. Recipients of a renal allograft, with a minimum age of 18 years.

2. Male or female recipients. Women of child-bearing age must practice adequate
contraception

3. For renal allografts from living donors, at least one HLA-mismatch is required.

4. Written informed consent, compliant with local regulations.

Exclusion Criteria:

1. Recipients of a second or third renal allograft, with a past history of graft failure
due to rejection.

2. Recipients of a renal allograft from a haplotype-identical living donor or a non-heart
beating donor.

3. Cold ischemia time > 24 hours

4. Recipients of a kidney from donors ≥ 65 years of age

5. Recipients of multiple organs.

6. Pregnant women.

7. Immunological high-risk recipients, defined as current or historical PRA > 50 %

8. Recipients with focal segmental sclerosis as primary renal disease.

9. Recipients with leucopenia (WBC < 3000/mm³), thrombocytopenia (Thr < 100.000/mm³),or
hyperlipidemia (Tot Chol > 300 mg/dl or Triglycerides > 300 mg/dl)

10. Previous history of malignancy, except completely excised basocellular skin tumor

11. Chronic active infection.

12. Inadequate compliance to treatment.

13. Use of specific drugs: Terfenadine, pimozide, astemizole, fluconazole, ketoconazole
and cimetidine.