Fibrosis in Renal Allografts
Interstitial Fibrosis in Protocol Biopsies of Renal Allografts: A Prospective, Randomised Trial of Sirolimus Versus Cyclosporine.(Fibrasic)
1 other identifier
interventional
100
1 country
3
Brief 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.
- 2.To determine the prognostic implication of these morphologic changes.
- 3.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2005
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedNovember 26, 2008
October 1, 2005
June 27, 2007
November 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Secundary end-points:
-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.
- +12 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Recipients of a renal allograft, with a minimum age of 18 years.
- Male or female recipients. Women of child-bearing age must practice adequate contraception
- For renal allografts from living donors, at least one HLA-mismatch is required.
- Written informed consent, compliant with local regulations.
You may not qualify if:
- Recipients of a second or third renal allograft, with a past history of graft failure due to rejection.
- Recipients of a renal allograft from a haplotype-identical living donor or a non-heart beating donor.
- Cold ischemia time \> 24 hours
- Recipients of a kidney from donors ≥ 65 years of age
- Recipients of multiple organs.
- Pregnant women.
- Immunological high-risk recipients, defined as current or historical PRA \> 50 %
- Recipients with focal segmental sclerosis as primary renal disease.
- Recipients with leucopenia (WBC \< 3000/mm³), thrombocytopenia (Thr \< 100.000/mm³),or hyperlipidemia (Tot Chol \> 300 mg/dl or Triglycerides \> 300 mg/dl)
- Previous history of malignancy, except completely excised basocellular skin tumor
- Chronic active infection.
- Inadequate compliance to treatment.
- Use of specific drugs: Terfenadine, pimozide, astemizole, fluconazole, ketoconazole and cimetidine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
- Hoffmann-La Rochecollaborator
Study Sites (3)
University Hospital Antwerp
Edegem, Antwerp, 9260, Belgium
University Hospital Brussels
Brussels (Jette), Brabant, 1090, Belgium
University Hospital Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Related Publications (4)
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 27;74(8):1070-6. doi: 10.1097/00007890-200210270-00002.
PMID: 12438948RESULTGroth CG, Backman L, Morales JM, Calne R, Kreis H, Lang P, Touraine JL, Claesson K, Campistol JM, Durand D, Wramner L, Brattstrom C, Charpentier B. Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group. Transplantation. 1999 Apr 15;67(7):1036-42. doi: 10.1097/00007890-199904150-00017.
PMID: 10221490RESULTKreis H, Cisterne JM, Land W, Wramner L, Squifflet JP, Abramowicz D, Campistol JM, Morales JM, Grinyo JM, Mourad G, Berthoux FC, Brattstrom C, Lebranchu Y, Vialtel P. Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients. Transplantation. 2000 Apr 15;69(7):1252-60. doi: 10.1097/00007890-200004150-00009.
PMID: 10798738RESULTGrimm 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. doi: 10.1097/01.asn.0000066143.02832.5e.
PMID: 12761269RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Louis Bosmans, M.D. Ph.D.
University Hospital, Antwerp
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 27, 2007
First Posted
June 28, 2007
Study Start
May 1, 2005
Study Completion
July 1, 2007
Last Updated
November 26, 2008
Record last verified: 2005-10