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Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- End-stage renal disease, with patients receiving a primary or secondary renal
allograft from a cadaveric donor, from a living-unrelated donor, or from a
living-related (excluding 0 antigen mismatch) donor.

- Women who are of childbearing potential must have a negative pregnancy test before
sirolimus administration and agree to use a medically acceptable method of
contraception throughout the treatment period and for 3 months following
discontinuation of sirolimus

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

- Evidence of active systemic or localized major infection at the time of initial
sirolimus administration

- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
pre-study screening.

- Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality
contraindicating general anesthesia or surgery

NCT00428064
Pfizer
Completed
Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

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Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients
A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Renal Transplantation
  • Drug: Sirolimus
  • Drug: cyclosporine
Not Provided
Friend P, Russ G, Oberbauer R, Murgia MG, Tufveson G, Chapman J, Blancho G, Mota A, Grandaliano G, Campistol JM, Brault Y, Burke JT; Rapamune Maintenance Regimen (RMR) Study Group. Incidence of anemia in sirolimus-treated renal transplant recipients: the importance of preserving renal function. Transpl Int. 2007 Sep;20(9):754-60. Epub 2007 Jun 12.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
408
June 2004
Not Provided

Inclusion Criteria:

  • End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
  • Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

Exclusion Criteria:

  • Evidence of active systemic or localized major infection at the time of initial sirolimus administration
  • Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
  • Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00428064
0468H1-310
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
January 2007

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

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[email protected]



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