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Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

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NCT00195468

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Curitiba, PR, 80730-150 Brazil
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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.
Kidney Failure, Graft vs Host Disease
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 with end-stage renal disease scheduled to receive a primary or secondary
renal allograft from a cadaveric donor, from a living-unrelated donor, or a
living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

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

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

NCT00195468
Pfizer
Completed
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

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Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Failure
  • Graft vs Host Disease
Drug: CYCLOSPORINE
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
November 2006
November 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

Exclusion Criteria:

  • Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Mexico
 
 
NCT00195468
0468H1-101116
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Brazil, [email protected]
Principal Investigator: Trial Manager For Mexico, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
December 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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