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

NCT00195429

Last updated date
Study Location
Sao Paulo, , , Brazil
Contact
1-800-718-1021

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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
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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
Official Title  ICMJE A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Failure
  • Graft vs Host Disease
Intervention  ICMJE
  • Drug: Tacrolimus
  • Drug: Sirolimus
  • Drug: prednisone
Study Arms  ICMJE
  • Experimental: Sirolimus + Tacrolimus
    Interventions:
    • Drug: Tacrolimus
    • Drug: Sirolimus
  • Active Comparator: Sirolimus + Prednisone
    Interventions:
    • Drug: Sirolimus
    • Drug: prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2010)
47
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
60
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195429
Other Study ID Numbers  ICMJE 0468E-101535
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Brazil, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP