Clinical trial NCT00311311: Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atherosclerosis
Kidney Failure
Keywords: Kidney transplant
Renal transplant
Immunosuppression
Atherosclerosis
Graft Rejection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 72
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
timeFrame: Pre-conversion baseline and 12 months post-transplant
measure: TPV at Pre-conversion Baseline
timeFrame: Pre-conversion baseline
Secondary outcomes:
measure: Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant
timeFrame: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
measure: CIMT at Pre-conversion Baseline
timeFrame: Pre-conversion baseline
measure: Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant
timeFrame: Pre-conversion baseline, 12, and 24 months post-transplant
measure: Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant
timeFrame: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant
timeFrame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
measure: Number of Participants Who Used Lipid Lowering Therapies
timeFrame: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
measure: Number of Participants Who Used Anti-hypertensive Medications
timeFrame: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
measure: Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant
timeFrame: Pre-conversion baseline, and 18, 24 and 36 months post-transplant
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: