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Xanthine Oxidase Inhibition in Renal Transplant Recipients (XART)

This study is currently recruiting participants. (see Contacts and Locations)
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

April 7, 2011
April 8, 2011
February 2011
February 2014   (final data collection date for primary outcome measure)
  • Cardiovascular events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01332799 on ClinicalTrials.gov Archive Site
Arterial stiffness and markers of inflammation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Xanthine Oxidase Inhibition in Renal Transplant Recipients
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Complications of Renal Transplant
Drug: allopurinol or placebo
Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
  • Active Comparator: Allopurinol
    Intervention: Drug: allopurinol or placebo
  • Placebo Comparator: Placebo (sugar pill)
    Intervention: Drug: allopurinol or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2016
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Roberto S Kalil, MD 319 384-7998 roberto-kalil@uiowa.edu
United States
 
NCT01332799
201010787
No
Roberto Kalil, MD, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Roberto S Kalil, MD University of Iowa
University of Iowa
April 2011

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