Interstitial Fibrosis in Protocol Biopsies of Renal Allografts: A prospective, randomised trial of Sirolimus versus Cyclosporine. - FIBRASIC

Phase 1

• Conditions: patients with end-stage renal failure treated with renal transplantation.

• Registration Number: EUCTR2004-004115-38-BE
• Lead Sponsor: niversity Hospital Antwerp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-12
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified