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Trial record 1 of 1 for:    NCT00195273
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Study Evaluating Sirolimus in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00195273
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : September 7, 2009
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE July 31, 2009
Results First Posted Date  ICMJE September 7, 2009
Last Update Posted Date April 28, 2010
Study Start Date  ICMJE November 2004
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Mean Creatinine Clearance Rate [ Time Frame: 12 months ]
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Assessment of kidney function after 3 and 12 months
Change History Complete list of historical versions of study NCT00195273 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
  • Number of Patients With Acute Rejection [ Time Frame: 3 and 12 months ]
    The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.
  • Patient and Graft Survival [ Time Frame: 12 months ]
    Graft survival is measured by graft loss which is defined as removal of the transplant.
  • Mean Creatinine Clearance Rate - 3 Months [ Time Frame: 3 months ]
    Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Incidence of acute rejection episodes after 3 and 12 months. Patient and graft survival after 3 and 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Sirolimus in Kidney Transplant Recipients
Official Title  ICMJE A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors
Brief Summary The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Graft vs Host Disease
  • Kidney Transplantation
Intervention  ICMJE
  • Drug: sirolimus
    15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
  • Drug: cyclosporine
    Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
  • Drug: mycophenolate mofetil
    1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
  • Drug: corticosteroids
    As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
  • Drug: daclizumab
    IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
Study Arms  ICMJE
  • Experimental: 1
    Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
    Interventions:
    • Drug: sirolimus
    • Drug: mycophenolate mofetil
    • Drug: corticosteroids
    • Drug: daclizumab
  • Active Comparator: 2
    Cyclosporine + Mycophenolate + Corticosteroids
    Interventions:
    • Drug: cyclosporine
    • Drug: mycophenolate mofetil
    • Drug: corticosteroids
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: July 31, 2009)
61
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
60
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Kidney transplantation
  • Donor must be at least 60 years old.

Exclusion Criteria:

  • Current systemic infection
  • Unstable angina or treatment for serious arrhythmia.
  • Cancer within the previous 5 years.
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 Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195273
Other Study ID Numbers  ICMJE 0468H-101466
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
Principal Investigator: Trial Manager For Norway, Sweden, MedInfoNord@wyeth.com
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