Xanthine Oxidase Inhibition in Renal Transplant Recipients

Complications of Renal Transplant Clinical Trial

— XART  

Official title:

Xanthine Oxidase Inhibition in Renal Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01332799
• Other study ID #: 201010787
• Status: Terminated
• Phase: Phase 4
• Start date: February 2011
• Est. completion date: August 10, 2018

Study information

• Verified date: September 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications of Renal Transplant

Intervention

Drug:
• allopurinol or placebo
Daily active drug (allopurinol administered orally) administered orally for 3 years.

Other:
• Placebo
Sugar pill administered orally for 3 years.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Roberto S Kalil

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Events	Number of major cardiovascular events	3 years
Primary	Endothelial Function	Changes in flow-mediated dilatation of braquial artery.	3 years
Secondary	Arterial Stiffness	Changes in pulse wave velocity.	3 years