Fibrosis in Renal Allografts

NCT00493194

Last updated date
Study Location
University Hospital Antwerp
Edegem, Antwerp, 9260, Belgium
Contact
..32/3/821 37 92

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Kidney Failure, Transplantation, Immunosuppression, Interstitial Fibrosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Chronic Kidney Failure, Transplantation, Immunosuppression, Interstitial FibrosisFibrosis in Renal Allografts
NCT00493194
  1. Edegem, Antwerp
  2. Brussels (Jette), Brabant
  3. Gent, Oost-Vlaanderen
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Fibrosis in Renal Allografts
Official Title  ICMJE Interstitial Fibrosis in Protocol Biopsies of Renal Allografts: A Prospective, Randomised Trial of Sirolimus Versus Cyclosporine.(Fibrasic)
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.

    • 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.
Detailed Description

Calcineurin inhibitors have significantly improved the one-year graft survival of renal allografts. However, chronic nephrotoxicity caused by calcineurin inhibitors contributes to the long-term decline in renal function in kidney transplant recipients. Approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity . In recent years, two new non-nephrotoxic immunosuppressive drugs, i.e. mycophenolate mofetil and sirolimus, have become available for the prophylaxis of graft rejection in renal transplantation.

Three randomized clinical trials, comparing cyclosporine with sirolimus in combination with mycophenolate mofetil, reported a superior graft function at one year in sirolimus treated renal allograft recipients. However, data on long-term graft survival and histological lesions of protocol biopsies in sirolimus-treated renal transplant recipients, are currently lacking.

In analogy with previous observations in native kidney disease, Grimm et al. recently reported that interstitial fibrosis in protocol biopsies of renal allografts, at 6 months post transplantation, significantly inversely correlates with the subsequent graft survival One hundred recipients of a first renal allograft will be randomized to an immunosuppressive protocol based on cyclosporine (50 patients) or sirolimus (50 patients). Concommittant immunosuppression will be similar in both groups, and consists of Daclizumab as induction treatment (five iv gifts every two weeks), and mycophenolate mophetil and steroids as maintenance immunosuppression.

Randomization will be performed by centre to avoid centre-related bias. All patients will complete a follow-up of 12 months. Two core biopsies of the graft will be obtained in each recipient, at implantation and at 6 months. Serum creatinine and the estimated creatinine clearance (by the Nankivell and the Jellife method) will be monthly recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Failure, Chronic
  • Transplantation
  • Immunosuppression
  • Interstitial Fibrosis
Intervention  ICMJE
  • Drug: sirolimus
  • Drug: cyclosporine
  • Drug: daclizumab
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 27, 2007)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00493194
Other Study ID Numbers  ICMJE 2004-004115-38
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator:Jean-Louis Bosmans, M.D. Ph.D.University Hospital, Antwerp
PRS Account University Hospital, Antwerp
Verification Date October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP