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A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Sao Paulo, , Brazil
Contact
1-800-718-1021
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
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 scheduled to receive a kidney transplant.

- Women who are of childbearing potential who are not pregnant and agree to use a
medically acceptable method of contraception throughout the treatment period and for 3
months following discontinuation of study drugs. Any woman becoming pregnant during
the treatment period must discontinue the use of study drugs;

- Signed informed consent.

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 study
drug administration;

- Multiple organ transplants;

- Any pathology or medical condition that can interfere with this protocol study
proposal.

Other exclusion applies.

NCT00195429
Pfizer
Completed
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

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A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.
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: Tacrolimus
  • Drug: Sirolimus
  • Drug: prednisone
  • Experimental: Sirolimus + Tacrolimus
    Interventions:
    • Drug: Tacrolimus
    • Drug: Sirolimus
  • Active Comparator: Sirolimus + Prednisone
    Interventions:
    • Drug: Sirolimus
    • Drug: prednisone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
October 2007
Not Provided

Inclusion Criteria:

  • End-stage renal disease, with patients scheduled to receive a kidney transplant.
  • Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
  • Signed informed consent.

Exclusion Criteria:

  • Evidence of active systemic or localized major infection at the time of initial study drug administration;
  • Multiple organ transplants;
  • Any pathology or medical condition that can interfere with this protocol study proposal.

Other exclusion applies.

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00195429
0468E-101535
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
Principal Investigator: Trial Manager For Brazil, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

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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