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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004115-38-BE

Enrollment

100

Registered

2005-12-12

Start date

2005-03-22

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with end-stage renal failure treated with renal transplantation.

Interventions

Trade Name: Rapamune Product Name: Rapamune Pharmaceutical Form: Tablet INN or Proposed INN: sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Trade Nam

Eligibility

Sex/Gender

All

Inclusion 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. 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

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 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.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: -Patient and graft-survival at one year. -The serum creatinine and the estimated creatinine clearance at 6 and 12 months. -The 24 hour proteinuria at 6 and 12 months. -The intimal area and arterial wall thickness in protocol biopsies at 6 months. -The glomerular volume in protocol biopsies at 6 months. -The incidence of acute rejection episodes during the first year. -The severity of acute rejection episodes according to the Banff ’97classification. -The incidence of infectious complications. -The incidence of hematological adverse effects. -The number of antihypertensive and lipid-lowering drugs at 6 and 12 months. -The incidence of treatment failure. ;Primary end point(s): 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, as described by Grimm et al..;Main Objective: This prospective, randomized study, comparing sirolimus to cyclosporine in renal transplant recipients, has two major objectives: 1°. A. To determine the incidence and the degree of interstitial fibrosis and arteriosclerosis, as well 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. 1°. B. To determine the prognostic implications 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.	—

Measure

Time frame

Secondary Objective: -Patient and graft-survival at one year. -The serum creatinine and the estimated creatinine clearance at 6 and 12 months. -The 24 hour proteinuria at 6 and 12 months. -The intimal area and arterial wall thickness in protocol biopsies at 6 months. -The glomerular volume in protocol biopsies at 6 months. -The incidence of acute rejection episodes during the first year. -The severity of acute rejection episodes according to the Banff ’97classification. -The incidence of infectious complications. -The incidence of hematological adverse effects. -The number of antihypertensive and lipid-lowering drugs at 6 and 12 months. -The incidence of treatment failure. ;Primary end point(s): 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, as described by Grimm et al..;Main Objective: This prospective, randomized study, comparing sirolimus to cyclosporine in renal transplant recipients, has two major objectives: 1°. A. To determine the incidence and the degree of interstitial fibrosis and arteriosclerosis, as well 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. 1°. B. To determine the prognostic implications 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.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026