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Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

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NCT00507793

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
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.
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

- At least 18 years of age

- End-stage renal disease in patients receiving a primary or secondary renal allograft
from a cadaveric, living-unrelated, or living-related mismatched donor

- Patients with secondary kidney transplant must have maintained primary graft for at
least 6 months

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

- Antibody induction within one week of current transplantation

- Multiorgan transplants

- Patients at high-risk of rejection

NCT00507793
Pfizer
Completed
Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

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Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus
An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Sirolimus
  • Drug: Cyclosporine
Not Provided
Mühlbacher F, Neumayer HH, del Castillo D, Stefoni S, Zygmunt AJ, Budde K; European Rapamune Cyclosporine Minimization Study Group. The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids: results from an open-label comparative study. Transpl Int. 2014 Feb;27(2):176-86. doi: 10.1111/tri.12228. Epub 2013 Nov 25.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
385
June 2002
Not Provided

Inclusion criteria

  • At least 18 years of age
  • End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
  • Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

Exclusion criteria

  • Antibody induction within one week of current transplantation
  • Multiorgan transplants
  • Patients at high-risk of rejection
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00507793
0468E1-4351
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 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.

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1-800-718-1021

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[email protected]



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