Xanthine Oxidase Inhibition in Renal Transplant Recipients

NCT ID: NCT01332799

Last Updated: 2019-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2018-08-10

Brief Summary

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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

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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.

Conditions

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Complications of Renal Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allopurinol

Group Type ACTIVE_COMPARATOR

allopurinol or placebo

Intervention Type DRUG

Daily active drug (allopurinol administered orally) administered orally for 3 years.

Placebo (sugar pill)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sugar pill administered orally for 3 years.

Interventions

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allopurinol or placebo

Daily active drug (allopurinol administered orally) administered orally for 3 years.

Intervention Type DRUG

Placebo

Sugar pill administered orally for 3 years.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roberto S Kalil

OTHER

Sponsor Role lead

Responsible Party

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Roberto S Kalil

Clinical Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Roberto S Kalil, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201010787

Identifier Type: -

Identifier Source: org_study_id

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