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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 : Terminated (Study was not funded)
First Posted : April 11, 2011
Results First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto S Kalil, University of Iowa

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 Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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
Actual Study Start Date : February 2011
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cardiovascular Events [ Time Frame: 3 years ]
    Number of major cardiovascular events

  2. Endothelial Function [ Time Frame: 3 years ]
    Changes in flow-mediated dilatation of braquial artery.


Secondary Outcome Measures :
  1. Arterial Stiffness [ Time Frame: 3 years ]
    Changes in pulse wave velocity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

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
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52240
Sponsors and Collaborators
Roberto S Kalil
Investigators
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Principal Investigator: Roberto S Kalil, MD University of Iowa
  Study Documents (Full-Text)

Documents provided by Roberto S Kalil, University of Iowa:
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Responsible Party: Roberto S Kalil, Clinical Professor of Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT01332799    
Other Study ID Numbers: 201010787
First Posted: April 11, 2011    Key Record Dates
Results First Posted: October 15, 2019
Last Update Posted: October 15, 2019
Last Verified: September 2019

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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
Keywords provided by Roberto S Kalil, University of Iowa:
cardiovascular disease
kidney transplantation
Additional relevant MeSH terms:
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Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs