Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

Back to Search
Print
Bookmark Trial

NCT00452361

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Select Cities, , , Taiwan
See other locations
Contact
1-800-718-1021
Cli[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplantation
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

- Subjects must be at least 18 years of age.

- Subjects who are 6 to 60 months after renal transplantation.

- Subjects who have a stable graft function.

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


- Subjects with active major infection, including HIV, decreased platelets, elevated
lipids, or multiple organ transplants.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Kidney TransplantationStudy Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
NCT00519116
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Kidney TransplantationCollection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
NCT01375127
  1. Los Angeles, California
  2. Los Angeles, California
  3. Palo Alto, California
  4. San Francisco, California
  5. San Francisco, California
  6. Stanford, California
  7. Aurora, Colorado
  8. Tampa, Florida
  9. Chicago, Illinois
  10. Chicago, Illinois
  11. Boston, Massachusetts
  12. Springfiled, Massachusetts
  13. Ann Arbor, Michigan
  14. Detroit, Michigan
  15. St. Louis, Missouri
  16. Livingston, New Jersey
  17. New York, New York
  18. Valhalla, New York
  19. Chapel Hill, North Carolina
  20. Dallas, Texas
  21. Dallas, Texas
  22. Fort Worth, Texas
  23. Richmond, Virginia
  24. Camperdown, New South Wales
  25. Westmead, New South Wales
  26. Adelaide, South Australia
  27. Clayton, Victoria
  28. Parkville, Victoria
  29. Anderlecht,
  30. Porto Alegre, RS
  31. Sao Paulo, SP
  32. Edmonton, Alberta
  33. Praha 4 - Krc,
  34. Nantes Cedex 1,
  35. Paris Cedex 15,
  36. Toulouse Cedex 9,
  37. Berlin,
  38. Hamburg,
  39. Roma,
  40. Rotterdam,
  41. Oslo,
  42. L'Hospitalet de Llobregat, Barcelona
  43. Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Kidney TransplantationA 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
NCT00106639
  1. Los Angeles, California
  2. Los Angeles, California
  3. Palo Alto, California
  4. San Diego, California
  5. San Francisco, California
  6. San Francisco, California
  7. Stanford, California
  8. Denver, Colorado
  9. Chicago, Illinois
  10. New Orleans, Louisiana
  11. St. Louis, Missouri
  12. St. Louis, Missouri
  13. Livingston, New Jersey
  14. New York, New York
  15. New York, New York
  16. Portland, Oregon
  17. Dallas, Texas
  18. Dallas, Texas
  19. Richmond, Virginia
  20. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Kidney TransplantationStudy of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
NCT00483756
  1. Little Rock, Arkansas
  2. Los Angeles, California
  3. Los Angeles, California
  4. Palo Alto, California
  5. San Diego, California
  6. San Francisco, California
  7. San Francisco, California
  8. Stanford, California
  9. Aurora, Colorado
  10. New Haven, Connecticut
  11. New Haven, Connecticut
  12. Gainesville, Florida
  13. Gainsville, Florida
  14. Tampa, Florida
  15. Chicago, Illinois
  16. Chicago, Illinois
  17. Baltimore, Maryland
  18. Boston, Massachusetts
  19. Springfield, Massachusetts
  20. Springfield, Massachusetts
  21. Ann Arbor, Michigan
  22. Detroit, Michigan
  23. Rochester, Minnesota
  24. St. Louis, Missouri
  25. Livingston, New Jersey
  26. New York, New York
  27. Valhalla, New York
  28. Chapel Hill, North Carolina
  29. Chapel Hill, North Carolina
  30. Chapel Hill, North Carolina
  31. Chapel Hill, North Carolina
  32. Portland, Oregon
  33. Philadelphia, Pennsylvania
  34. Charleston, South Carolina
  35. Dallas, Texas
  36. Dallas, Texas
  37. Fort Worth, Texas
  38. Camperdown, New South Wales
  39. Westmead, New South Wales
  40. Adelaide, South Australia
  41. Woodville, South Australia
  42. Clayton, Victoria
  43. Parkville, Victoria
  44. Anderlecht,
  45. Leuven,
  46. Porto Alegre, RS
  47. Sao Paulo, SP
  48. Sao Paulo, SP
  49. Edmonton, Alberta
  50. Praha 4,
  51. Nantes,
  52. Paris Cedex 15,
  53. Toulouse Cedex 9,
  54. Vandoeuvre Les Nancy,
  55. Berlin,
  56. Hamburg,
  57. Bologna,
  58. Roma,
  59. Seoul,
  60. Seoul,
  61. Seoul,
  62. Rotterdam,
  63. Oslo,
  64. Warszawa,
  65. Wroclaw,
  66. Coimbra,
  67. Lisboa,
  68. Hospitalet de Llobregat, Barcelona
  69. Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
Official Title  ICMJE A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient
Brief Summary This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).
Detailed Description

This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.

The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B).

Dosage and Administration

SRL Therapy: At the time of randomization on day 1, each patient will have been receiving:

  • triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND
  • corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS
  • either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization.

SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.

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 Transplantation
Intervention  ICMJE
  • Drug: Sirolimus+MMF or MPS or AZA+Steroid
    Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
  • Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid

    The maintenance dose of:

    1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day
    2. AZA will not exceed 75 mg/day

    Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:

    1. continued for the entire 104-week period of randomized therapy
    2. subsequently discontinued
    3. restarted after discontinuation
Study Arms  ICMJE
  • Experimental: 1
    Sirolimus therapy
    Intervention: Drug: Sirolimus+MMF or MPS or AZA+Steroid
  • Active Comparator: 2
    Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)
    Intervention: Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 27, 2012)		31
Original Enrollment  ICMJE
 (submitted: March 26, 2007)		120
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be at least 18 years of age.
  • Subjects who are 6 to 60 months after renal transplantation.
  • Subjects who have a stable graft function.

Exclusion Criteria:

  • Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.
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 Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452361
Other Study ID Numbers  ICMJE 0468H-101864
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2012

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