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Trial record 1 of 1 for:    NCT00254709
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Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00254709
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE November 11, 2005
First Posted Date  ICMJE November 16, 2005
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00254709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • Incidence of acute rejections at 3 and 12 months
  • Patient and graft survival at 3 and 12 months
  • Incidence and duration of episodes of acute tubular necrosis
  • Time to recover renal function (creatinine< 2 mg/dl)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
Official Title  ICMJE Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population
Brief Summary The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.
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 Rejection
  • Aged
Intervention  ICMJE Drug: Sirolimus
Study Arms  ICMJE Not Provided
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: January 26, 2012)
66
Original Enrollment  ICMJE
 (submitted: November 14, 2005)
80
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • End stage renal disease
  • Kidney transplantation
  • Both donor and recipient older than 60 years

Exclusion Criteria:

  • Prior or concurrent transplant of any organ other than the kidney
  • Current clinically significant infections
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254709
Other Study ID Numbers  ICMJE 0468-100970
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date January 2012

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