Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

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NCT00369382

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Study Location
Pfizer Investigational Site
Tampa, Florida, 33606, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Graft Rejection, Kidney Failure
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

- Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.

- 12 months after cardiac transplantation but less than 96 months post-transplantation.

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


- Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after
kidney transplant recipients).


- Prior or current use of sirolimus or everolimus unless administration was part of a
"CNI holiday" lasting no more than 10 days.


- History of acute rejection within the last 3 months, malignancy within the last 5
years (except for adequately treated basal cell or squamous cell carcinoma of the
skin), and human immunodeficiency virus (HIV) patients.

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Graft Rejection, Kidney FailureStudy Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
NCT00369382
  1. Tampa, Florida
  2. Rochester, Minnesota
  3. New York, New York
  4. Philadelphia, Pennsylvania
  5. Philadelphia, Pennsylvania
  6. Pittsburgh, Pennsylvania
  7. Houston, Texas
  8. Norfolk, Virginia
  9. Darlinghurst, New South Wales
  10. Vienna,
  11. Montreal, Quebec
  12. Sainte-Foy, Quebec
  13. Quebec,
  14. Epsom, Auckland
  15. Auckland,
  16. L'Hospitalet de Llobregat, Barcelona
  17. Santander, Cantabria
  18. Barcelona,
  19. La Coru?a,
  20. Madrid,
  21. Sevilla,
  22. Valencia,
  23. Bern,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
Official Title  ICMJE A Randomized Open-Label Study To Compare The Safety And Efficacy Of Conversion From A Calcineurin Inhibitor To Sirolimus Vs Continued Use Of A Calcineurin Inhibitor In Heart Transplant Recipients With Mild-Moderate Impaired Renal Function
Brief Summary The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Graft Rejection
  • Kidney Failure
Intervention  ICMJE
  • Drug: cyclosporine or tacrolimus
    Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
    Other Name: Brand names for cyclosporine are Neoral®, Sandimmune®, and Gengraf®; brand names for tacrolimus are Prograf® and Adagraf?.
  • Drug: sirolimus
    Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
    Other Name: Rapamune®
Study Arms  ICMJE
  • Active Comparator: 1
    Group 1: Continuation of CNI regimen
    Intervention: Drug: cyclosporine or tacrolimus
  • Experimental: 2
    Group 2: (CNI-Free) Conversion to SRL-based regimen
    Intervention: Drug: sirolimus
Publications * Zuckermann A, Keogh A, Crespo-Leiro MG, Mancini D, Vilchez FG, Almenar L, Brozena S, Eisen H, Tai SS, Kushwaha S. Randomized controlled trial of sirolimus conversion in cardiac transplant recipients with renal insufficiency. Am J Transplant. 2012 Sep;12(9):2487-97. doi: 10.1111/j.1600-6143.2012.04131.x. Epub 2012 Jul 9.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2010)		121
Original Enrollment  ICMJE
 (submitted: August 25, 2006)		200
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
  • 12 months after cardiac transplantation but less than 96 months post-transplantation.

Exclusion Criteria:

  • Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
  • Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
  • History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.
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 Australia,   Austria,   Canada,   New Zealand,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00369382
Other Study ID Numbers  ICMJE 0468E7-408
B1741006 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2011

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