Back to resultsUse of Febuxostat in Hyperuricemia Among Hemodialysis Patients
Primary Purpose
Hyperuricemia, Hemodialysis Complication
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Febuxostat 40 milligramsTablet
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in serum uric acid
Change in serum uric acid after 3 months of Febuxostat 40 milligrams Tablet therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT03149939
First Posted
May 10, 2017
Last Updated
May 10, 2017
Sponsor
Benha University
Collaborators
New Jeddah Clinic Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03149939
Brief Title
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
Official Title
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
New Jeddah Clinic Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Hemodialysis Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Febuxostat 40 milligramsTablet
Intervention Description
Febuxostat 40 milligramsTablet every other day for 3 months
Primary Outcome Measure Information:
Title
Change in serum uric acid
Description
Change in serum uric acid after 3 months of Febuxostat 40 milligrams Tablet therapy
Time Frame
at three months of Febuxostat 40 milligrams Tablet therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
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