|
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: |
NCT00195468 |
|
Date of registration:
|
13/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
|
|
Scientific title:
|
A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune. |
|
Date of first enrolment:
|
March 2004 |
|
Target sample size:
|
280 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00195468 |
|
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
|
|
|
Countries of recruitment
|
|
Brazil
|
Mexico
| | | | | | |
|
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 Mexico, gomezlj@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Brazil, xavierl@wyeth.com |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Subjects with end-stage renal disease scheduled to receive a primary or secondary
renal allograft from a cadaveric donor, from a living-unrelated donor, or a
living-related HLA-mismatched donor. Subjects must be at least 18 years of age.
Exclusion Criteria:
- Subjects with active major infection, including active hepatitis B or C infection,
decreased platelets, elevated lipids, or multiple organ transplants.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Graft vs Host Disease
|
|
Kidney Failure
|
|
Intervention(s)
|
|
Drug: CYCLOSPORINE
|
|
Primary Outcome(s)
|
|
Calculated creatinine clearance at 12 months post transplantation for patients on therapy.
|
|
Secondary Outcome(s)
|
|
Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.
|
|
Secondary ID(s)
|
|
0468H1-101116
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|