Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
NCT00261820
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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 |
| |||||||||
| Intervention ICMJE |
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| 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 | 160 | |||||||||
| Original Enrollment ICMJE | Same as current | |||||||||
| Study Completion Date ICMJE | January 2005 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||
| Sex/Gender ICMJE |
| |||||||||
| 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 |
| |||||||||
| 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 | ||||||||||