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Trial record 1 of 1 for:    NCT00518271
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Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

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ClinicalTrials.gov Identifier: NCT00518271
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : August 20, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE July 26, 2007
First Posted Date  ICMJE August 20, 2007
Last Update Posted Date August 20, 2007
Study Start Date  ICMJE April 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2007)
Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2007)
Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.
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 Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
Official Title  ICMJE A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
Brief Summary This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.
Detailed Description This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE
  • Drug: Rapamune® (Sirolimus)
  • Drug: Tacrolimus
  • Drug: Corticosteroids
    Perioperative
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: August 16, 2007)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion criteria

  • At least 18 years of age
  • End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor
  • Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

  • Planned antibody induction
  • Multiple organ transplants
  • Patients at high risk of acute rejection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT00518271
Other Study ID Numbers  ICMJE 0468E1-100193
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 Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2007

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