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.