Kidney Failure, Chronic Clinical Trial
Official title:
Interstitial Fibrosis in Protocol Biopsies of Renal Allografts: A Prospective, Randomised Trial of Sirolimus Versus Cyclosporine.(Fibrasic)
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Brussels | Brussels (Jette) | Brabant |
Belgium | University Hospital Antwerp | Edegem | Antwerp |
Belgium | University Hospital Gent | Gent | Oost-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Hoffmann-La Roche, Wyeth is now a wholly owned subsidiary of Pfizer |
Belgium,
Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct — View Citation
Grimm PC, Nickerson P, Gough J, McKenna R, Stern E, Jeffery J, Rush DN. Computerized image analysis of Sirius Red-stained renal allograft biopsies as a surrogate marker to predict long-term allograft function. J Am Soc Nephrol. 2003 Jun;14(6):1662-8. — View Citation
Groth CG, Bäckman L, Morales JM, Calne R, Kreis H, Lang P, Touraine JL, Claesson K, Campistol JM, Durand D, Wramner L, Brattström C, Charpentier B. Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity — View Citation
Kreis H, Cisterne JM, Land W, Wramner L, Squifflet JP, Abramowicz D, Campistol JM, Morales JM, Grinyo JM, Mourad G, Berthoux FC, Brattström C, Lebranchu Y, Vialtel P. Sirolimus in association with mycophenolate mofetil induction for the prevention of acut — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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, | |||
Secondary | Secundary end-points: | |||
Secondary | -Patient and graft-survival at one year. | |||
Secondary | -The serum creatinine and the estimated creatinine | |||
Secondary | clearance at 6 and 12 months. | |||
Secondary | -The 24 hour proteinuria at 6 and 12 months. | |||
Secondary | -The intimal area and arterial wall thickness in protocol | |||
Secondary | biopsies at 6 months. | |||
Secondary | -The glomerular volume in protocol biopsies at 6 months. | |||
Secondary | -The incidence of acute rejection episodes during the | |||
Secondary | first year. | |||
Secondary | -The severity of acute rejection episodes according to | |||
Secondary | the Banffâ 97 classification. | |||
Secondary | -The incidence of infectious complications. | |||
Secondary | -The incidence of hematological adverse effects. | |||
Secondary | -The number of antihypertensive and lipid-lowering drugs | |||
Secondary | at 6 and 12 months. | |||
Secondary | -The incidence of treatment failure. |
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