Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

NCT00261820

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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 < 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
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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Graft Rejection
  • Kidney Failure
  • Kidney Transplantation
Intervention  ICMJE
  • Drug: tacrolimus
  • Drug: mycophenolate mofetil
  • Drug: methylprednisolone
  • Drug: prednisolone
  • Drug: sirolimus
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: December 2, 2005)
160
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00261820
Other Study ID Numbers  ICMJE 0468E1-100194
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP