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Study Evaluating Sirolimus in Kidney Transplant Recipients

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Oslo, , N-0027 Norway
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Graft vs Host Disease, Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Kidney transplantation

- Donor must be at least 60 years old.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Current systemic infection

- Unstable angina or treatment for serious arrhythmia.

- Cancer within the previous 5 years.

NCT00195273
Pfizer
Completed
Study Evaluating Sirolimus in Kidney Transplant Recipients

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Study Evaluating Sirolimus in Kidney Transplant Recipients
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Graft vs Host Disease
  • Kidney Transplantation
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
July 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden
 
 
NCT00195273
0468H-101466
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Norway, Sweden, [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

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1-800-718-1021

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