HyperuricemiaNCT03149939
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
A study testing Febuxostat 40 milligramsTablet in people with Hyperuricemia and Hemodialysis Complication, run by Benha University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperuricemia, Hemodialysis Complication
- What is being tested?
- Febuxostat 40 milligramsTablet
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Hemodialysis patient
- Hyperuricemia (Uric acid level above 6.0 mg/dL in females and 7.0 mg/dL in males)
Who cannot join
- 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
About this study
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.
- Conditions
- Hyperuricemia, Hemodialysis Complication
- Being tested
- Febuxostat 40 milligramsTablet
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Febuxostat 40 milligramsTabletDrug
Febuxostat 40 milligramsTablet every other day for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum uric acid
Change in serum uric acid after 3 months of Febuxostat 40 milligrams Tablet therapy
Measured: at three months of Febuxostat 40 milligrams Tablet therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Jan 2017
- Primary completion1 Apr 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149939
- Sponsor's protocol ID
- BN-0316
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03149939
- Acronym / sponsor ID
- BN-0316
- Conditions
- Hyperuricemia, Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years
- Hemodialysis patient
- Hyperuricemia (Uric acid level above 6.0 mg/dL in females and 7.0 mg/dL in males)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Febuxostat 40 milligramsTabletFebuxostat 40 milligramsTablet every other day for 3 months | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Febuxostat 40 milligramsTablet in people with Hyperuricemia and Hemodialysis Complication, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum uric acid (time frame: at three months of Febuxostat 40 milligrams Tablet therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.