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Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

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NCT00257387

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant
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 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,
HIV, decreased platelets, elevated lipids, or multiple organ transplants.

NCT00257387
Pfizer
Completed
Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

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Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants
A Nonrandomized, Open-label, Multicenter, Sequential Phase Study to Evaluate the Safety and Efficacy of Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese De Novo Renal Allograft Recipients Receiving Rapamune
Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Kidney Transplant
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
120
August 2006
Not Provided

Inclusion Criteria:

  • Subjects with end-stage renal disease scheduled to receive a primary 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, HIV, 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
Not Provided
 
 
NCT00257387
0468H1-101308
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
June 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

BY EMAIL

Contact

[email protected]



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