Study Stopped
Study was not funded
Xanthine Oxidase Inhibition in Renal Transplant Recipients
XART
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2018
CompletedResults Posted
Study results publicly available
October 15, 2019
CompletedOctober 15, 2019
September 1, 2019
7.5 years
April 7, 2011
July 12, 2019
September 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cardiovascular Events
Number of major cardiovascular events
3 years
Endothelial Function
Changes in flow-mediated dilatation of braquial artery.
3 years
Secondary Outcomes (1)
Arterial Stiffness
3 years
Study Arms (2)
Allopurinol
ACTIVE COMPARATORPlacebo (sugar pill)
PLACEBO COMPARATORInterventions
Daily active drug (allopurinol administered orally) administered orally for 3 years.
Eligibility Criteria
You may qualify if:
- age 18 years or older
- both genders
- recipients of living donor or deceased-donor kidney transplant with stable renal function
You may not qualify if:
- history of gout
- allergy to allopurinol
- use of azathioprine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roberto S Kalillead
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52240, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study did not receive funding so intervention did not begin.
Results Point of Contact
- Title
- Dr. Roberto Kalil
- Organization
- University of Iowa
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto S Kalil, MD
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor of Medicine
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 11, 2011
Study Start
February 1, 2011
Primary Completion
August 10, 2018
Study Completion
August 10, 2018
Last Updated
October 15, 2019
Results First Posted
October 15, 2019
Record last verified: 2019-09