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Xanthine Oxidase Inhibition in Renal Transplant Recipients (XART)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332799
First Posted: April 11, 2011
Last Update Posted: March 28, 2017
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.
Information provided by (Responsible Party):
Roberto S Kalil, University of Iowa
April 7, 2011
April 11, 2011
March 28, 2017
February 2011
March 2018   (Final data collection date for primary outcome measure)
  • Cardiovascular events [ Time Frame: 3 years ]
  • Endothelial function [ Time Frame: 3 years ]
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 ]
Same as current
Not Provided
Not Provided
 
Xanthine Oxidase Inhibition in Renal Transplant Recipients
Xanthine Oxidase Inhibition in Renal Transplant Recipients
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Active, not recruiting
120
March 2018
March 2018   (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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01332799
201010787
No
Not Provided
Not Provided
Roberto S Kalil, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Roberto S Kalil, MD University of Iowa
University of Iowa
March 2017

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