Xanthine Oxidase Inhibition in Renal Transplant Recipients (XART)

This study is currently recruiting participants.

Verified April 2011 by University of Iowa

Sponsor:

Information provided by:

University of Iowa

ClinicalTrials.gov Identifier:

NCT01332799

First received: April 7, 2011

Last updated: April 8, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 7, 2011

Last Updated Date

April 8, 2011

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiovascular events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Endothelial function [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01332799 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Arterial stiffness and markers of inflammation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Xanthine Oxidase Inhibition in Renal Transplant Recipients

Official Title ^ICMJE

Not Provided

Brief Summary

Cardiovascular disease is the leading cause of mortality in kidney transplantation. The enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health and protects against cardiovascular complications.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Complications of Renal Transplant

Intervention ^ICMJE

Drug: allopurinol or placebo

Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.

Study Arm (s)

Active Comparator: Allopurinol
Intervention: Drug: allopurinol or placebo
Placebo Comparator: Placebo (sugar pill)
Intervention: Drug: allopurinol or placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

February 2016

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age 18 years or older
both genders
recipients of living donor or deceased-donor kidney transplant with stable renal function

Exclusion Criteria:

history of gout
allergy to allopurinol
use of azathioprine

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Roberto S Kalil, MD

319 384-7998

roberto-kalil@uiowa.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01332799

Other Study ID Numbers ^ICMJE

201010787

Has Data Monitoring Committee

Responsible Party

Roberto Kalil, MD, University of Iowa

Study Sponsor ^ICMJE

University of Iowa

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Roberto S Kalil, MD

University of Iowa

Information Provided By

University of Iowa

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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