Xanthine Oxidase Inhibition in Renal Transplant Recipients (XART)

September 25, 2019 updated by: Roberto S Kalil
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, double-blind, placebo controlled, clinical trial examining vascular effects of allopurinol in patients who received a kidney transplant that are maintaining stable renal function for at least 1 year. End-points include pulse-wave velocity, systemic blood pressure and kidney function among others.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Allopurinol
Drug: allopurinol or placebo
Daily active drug (allopurinol administered orally) administered orally for 3 years.
PLACEBO_COMPARATOR: Placebo (sugar pill)
Other: Placebo
Sugar pill administered orally for 3 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Events
Time Frame: 3 years
Number of major cardiovascular events
3 years
Endothelial Function
Time Frame: 3 years
Changes in flow-mediated dilatation of braquial artery.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Stiffness
Time Frame: 3 years
Changes in pulse wave velocity.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roberto S Kalil

Investigators

  • Principal Investigator: Roberto S Kalil, MD, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2011

Primary Completion (ACTUAL)

August 10, 2018

Study Completion (ACTUAL)

August 10, 2018

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (ESTIMATE)

April 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201010787

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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