Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients

May 10, 2017 updated by: Mahmoud Hamada imam, Benha University
Hyperuricemia is not infrequently encountered among hemodialysis patients. However, there is no clear data about use of febuxostat among hemodialysis patients, apart from very small case series. The aim of this study is to investigate the efficacy of using febuxostat for the treatment of Hyperuricemia among hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age above 18 years
  • Hemodialysis patient
  • Hyperuricemia (Uric acid level above 6.0 mg/dL in females and 7.0 mg/dL in males)

Exclusion Criteria:

  • Patient currently and/or recently received drugs for hyperuricemia within the last three months
  • Patient had recent (within 3 months) change of erythropoiesis stimulating drugs or other drug known to increase uric acid e.g furosemide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum uric acid
Time Frame: at three months of Febuxostat 40 milligrams Tablet therapy
Change in serum uric acid after 3 months of Febuxostat 40 milligrams Tablet therapy
at three months of Febuxostat 40 milligrams Tablet therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Collaborators

New Jeddah Clinic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BN-0316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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