|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00261820 |
|
Date of registration:
|
02/12/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
June 2005 |
|
Target sample size:
|
160 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00261820 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Contacts
|
|
Name:
|
Medical Monitor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wyeth is now a wholly owned subsidiary of Pfizer |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Belgium, trials-BEL@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For France, infomedfrance@wyeth.com |
|
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Graft Rejection
|
|
Kidney Transplantation
|
|
Kidney Failure
|
|
Intervention(s)
|
|
Drug: sirolimus
|
|
Drug: mycophenolate mofetil
|
|
Drug: prednisolone
|
|
Drug: methylprednisolone
|
|
Drug: tacrolimus
|
|
Primary Outcome(s)
|
|
transplantation.
|
|
- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
|
|
Secondary Outcome(s)
|
|
Incidence of document infection
|
|
criteria at 3, 6 and 12 Months following transplantation
|
|
Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
|
|
One year graft biopsy status
|
|
Secondary ID(s)
|
|
0468E1-100194
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|