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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


Phase 3
35 Years
N/A
Not Enrolling
Both
Atherosclerosis, Kidney Failure

Thank you

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