Study Comparing Conversion From Tacrolimus to Sirolimus at 3-4 Months Post-Transplant in Kidney Transplant Patients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00311311

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis Kidney Failure	Drug: tacrolimus Drug: sirolimus Drug: mycophenolate mofetil Drug: prednisone	Phase III

MedlinePlus related topics: Kidney Failure Kidney Transplantation

Drug Information available for: Prednisone Sirolimus Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

The change in plaque volume in the distal common carotid arteries from the pre-conversion baseline to 12 months following conversion [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The changes in other measures of carotid plaque volume, intima media thickness, biochemical markers of cardiovascular disease, and cardiovascular outcomes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	March 2006
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: tacrolimus Drug: mycophenolate mofetil Drug: prednisone
2: Experimental	Drug: sirolimus

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).
Active gastrointestinal disease that may interfere with drug absorption.
Active HIV, hepatitis B or C infection.
Women who are pregnant or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311311

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, New York
	Recruiting
Rochester, New York, United States, 14642
Canada, Alberta
	Recruiting
Edmonton, Alberta, Canada, T6G 2G3
	Recruiting
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
	Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
	Recruiting
Hamilton, Ontario, Canada, L8N 4A6
	Recruiting
London, Ontario, Canada, N6A 5A5
Canada, Quebec
	Recruiting
Montreal, Quebec, Canada, H1T-2M4

Sponsors and Collaborators

Wyeth

Investigators

Principal Investigator:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468H1-101995
Study First Received:	April 3, 2006
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00311311 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Wyeth:

Kidney transplant
Renal transplant
Immunosuppression

Atherosclerosis
Graft Rejection
Kidney Transplant

Study placed in the following topic categories:

Sirolimus
Atherosclerosis
Anti-Inflammatory Agents
Prednisone
Renal Insufficiency
Immunologic Factors
Clotrimazole
Hormone Antagonists
Miconazole
Hormones, Hormone Substitutes, and Hormone Antagonists
Tacrolimus
Arteriosclerosis
Hormones

Anti-Bacterial Agents
Urologic Diseases
Antifungal Agents
Mycophenolate mofetil
Kidney Diseases
Arterial Occlusive Diseases
Antineoplastic Agents, Hormonal
Vascular Diseases
Tioconazole
Glucocorticoids
Immunosuppressive Agents
Kidney Failure

Additional relevant MeSH terms:

Sirolimus
Atherosclerosis
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Renal Insufficiency
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Tacrolimus
Arteriosclerosis
Antibiotics, Antineoplastic
Hormones

Anti-Bacterial Agents
Urologic Diseases
Therapeutic Uses
Antifungal Agents
Mycophenolate mofetil
Cardiovascular Diseases
Kidney Diseases
Arterial Occlusive Diseases
Antineoplastic Agents, Hormonal
Vascular Diseases
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009