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Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Last updated on October 5, 2018

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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.
Graft Rejection, Kidney Failure, Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age: 18 and

- End-stage renal disease, with patients scheduled to receive a primary renal allograft
from a cadaveric donor

- Patients receiving a second transplant without an immunological loss of their first
graft in the first six months of transplant

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

- Evidence of active systemic or localized major infection at the time of initial
sirolimus administration

- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
pre-study screening

- Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the
study and during the 12-month treatment phase

NCT00261820
Pfizer
Completed
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

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Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Graft Rejection
  • Kidney Failure
  • Kidney Transplantation
  • Drug: tacrolimus
  • Drug: mycophenolate mofetil
  • Drug: methylprednisolone
  • Drug: prednisolone
  • Drug: sirolimus
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
160
January 2005
Not Provided

Inclusion Criteria:

  • Age: 18 and < 65 years
  • End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
  • Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant

Exclusion Criteria:

  • Evidence of active systemic or localized major infection at the time of initial sirolimus administration
  • Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
  • Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00261820
0468E1-100194
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
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

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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