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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
  Purpose

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 Intervention Phase
Complications of Renal Transplant
 Drug: allopurinol or placebo
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

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

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

Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332799

Contacts
Contact: Roberto S Kalil, MD 319 384-7998 roberto-kalil@uiowa.edu

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

No publications provided

Responsible Party: Roberto Kalil, MD, University of Iowa
ClinicalTrials.gov Identifier: NCT01332799     History of Changes
Other Study ID Numbers: 201010787
Study First Received: April 7, 2011
Last Updated: April 8, 2011
Health Authority: United States: University of Iowa Institutional Review Board
United States: Institutional Review Board

Keywords provided by University of Iowa:
cardiovascular disease
kidney transplantation

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

ClinicalTrials.gov processed this record on May 16, 2013