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Xanthine Oxidase Inhibition in Renal Transplant Recipients (XART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01332799
Recruitment Status : Active, not recruiting
First Posted : April 11, 2011
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Complications of Renal Transplant Drug: allopurinol or placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Xanthine Oxidase Inhibition in Renal Transplant Recipients
Study Start Date : February 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Allopurinol Drug: allopurinol or placebo
Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
Placebo Comparator: Placebo (sugar pill) Drug: allopurinol or placebo
Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.


Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 3 years ]
  2. Endothelial function [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Arterial stiffness and markers of inflammation [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332799


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52240
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Roberto S Kalil, MD University of Iowa
More Information

Responsible Party: Roberto S Kalil, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01332799     History of Changes
Other Study ID Numbers: 201010787
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Roberto S Kalil, University of Iowa:
cardiovascular disease
kidney transplantation

Additional relevant MeSH terms:
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs