You are here

Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Last updated on May 10, 2018

FOR MORE INFORMATION
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 donor

- Patients with secondary kidney transplant must have maintained their 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

- Patients at high risk of acute rejection

NCT00518271
Pfizer
Completed
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Rapamune® (Sirolimus)
  • Drug: Tacrolimus
  • Drug: Corticosteroids
    Perioperative
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
120
June 2002
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 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
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
 
 
NCT00518271
0468E1-100193
Not Provided
Not Provided
Not Provided
Not Provided
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
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now