Use of Febuxostat in Hyperuricemia Among Hemodialysis Pat... | NCT03149939

Studies
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients

NCT03149939

Sponsor

Benha University

Status

Completed

Last Update Posted

May 11, 2017Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Hyperuricemia
Hemodialysis Complication

Interventions

Febuxostat 40 milligramsTablet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Apr 1, 2017Actual

Completion Date

May 1, 2017Actual

First Submitted Date

May 10, 2017

First Submission Date that Met QC Criteria

May 10, 2017

First Posted Date

May 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2017

Last Update Posted Date

May 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Hamada imam, MD. - Lecturer at Internal Medicine Department- Faculty of Medicine, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Name	Class
New Jeddah Clinic Hospital	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Febuxostat 40 milligramsTablet	Drug	Febuxostat 40 milligramsTablet every other day for 3 months

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D033461	Hyperuricemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided