You are here

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

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tampa, Florida, 33606 United States
Contact
1-800-718-1021
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.

NCT00369382
Pfizer
Completed
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

NEED INFO?

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

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 zip code, city, or country to find studies near you.

Similar Trials

Kidney Transplantation
NCT00484094
All Genders
13+
Years
Multiple Sites
Kidney Transplantation
NCT01375127
All Genders
18+
Years
Multiple Sites
Chronic Heart Failure
NCT03342690
All Genders
0+
Years
Tokyo,
Kidney Neoplasms
NCT00920816
All Genders
18+
Years
Multiple Sites
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Graft Rejection
  • Kidney Failure
  • 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®
  • 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
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.
 
Completed
121
May 2010
April 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   New Zealand,   Spain,   Switzerland,   United States
 
 
NCT00369382
0468E7-408
B1741006 ( Other Identifier: Pfizer )
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now