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Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

Last updated on December 15, 2017

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- At least 18 years of age

- End-stage renal disease in patients receiving a primary or secondary renal allograft
from a cadaveric, living-unrelated, or living-related mismatched donor

- Patients with a secondary transplant must have maintained a primary graft for at least
6 months

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

- Planned antibody induction

- Multiple organ transplants

- History of malignancy within five years of enrollment

NCT00519116
Pfizer
Completed
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

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Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
An 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
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Rapamune® (Sirolimus)
  • Drug: Tacrolimus
  • Drug: Perioperative Corticosteroids
    The corticosteroids use was left up to the investigators decision.
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2001
Not Provided

Inclusion criteria:

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

Exclusion criteria:

  • Planned antibody induction
  • Multiple organ transplants
  • History of malignancy within five years of enrollment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00519116
0468E1-100539
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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