Xanthine Oxidase Inhibition in Renal Transplant Recipients

Phase 4

Terminated

• Conditions: Complications of Renal Transplant
• Interventions: Drug: allopurinol or placebo; Other: Placebo

• Registration Number: NCT01332799
• Lead Sponsor: Roberto S Kalil

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.

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Results First Submitted: 2019-07-12
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Results First Posted: 2019-10-15
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allopurinol	allopurinol or placebo	-
Placebo (sugar pill)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular Events	3 years	Number of major cardiovascular events
Endothelial Function	3 years	Changes in flow-mediated dilatation of braquial artery.

Secondary Outcome Measures

Name	Time	Method
Arterial Stiffness	3 years	Changes in pulse wave velocity.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States