A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients
35 Years
N/A
Both
Atherosclerosis, Kidney Failure
Trial Information
A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients
A decision to terminate the study was taken in November 2011 and a communication to that
effect sent to all participating sites on November 18. All sites were asked to have patients
returned to the sites and have all end of study procedures performed by Dec 31, 2011.
The decision to terminate this study was made following the conduct of an interim analysis
which demonstrated that the study did not reach its primary endpoint. The termination of
this study was not driven by any safety concerns and had no impact on subject safety and
well-being.
Inclusion Criteria:
At least one of the following characteristics:
- History of dialysis for at least 3 years.
- History of diabetes for at least 5 years.
- Hypertension or ischemic nephropathy as a cause of the end stage renal disease or
loss of the first transplant.
- History of coronary artery disease, stroke, myocardial infarction, or amputation for
vascular disease.
Exclusion Criteria:
- History of malignancy within the last 5 years (except adequately treated skin
cancer).
- Recipients of non-renal organ transplant.
- Active gastrointestinal disease that may interfere with drug absorption.
- Active HIV, hepatitis B or C infection.
- Women who are pregnant or breastfeeding.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Total Plaque Volume (TPV) Annual Rate of Change From Pre-conversion Baseline to 12 Months Post Transplant
Outcome Description:
Annual rate of change in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Outcome Time Frame:
12 Months Post-Transplant
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Canada: Health Canada
Study ID:
0468H1-319
NCT ID:
NCT00311311
Start Date:
April 2006
Completion Date:
January 2012
Related Keywords:
- Atherosclerosis
- Kidney Failure
- Kidney transplant
- Renal transplant
- Immunosuppression
- Atherosclerosis
- Graft Rejection
- Kidney Transplant
- Atherosclerosis
- Renal Insufficiency
- Carotid Artery Diseases
Name | Location |
|---|---|
| Pfizer Investigational Site | Bronx, New York 10461 |
