Endothelial DysfunctionPhase 2/3NCT02866214
Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
A Phase 2/3 study testing Febuxostat in people with Endothelial Dysfunction and Endstage Renal Disease, run by Ain Shams University.
Trial summary
The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Endstage Renal Disease
- What is being tested?
- Febuxostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Oct 2016
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients on maintenance hemodialysis.
- Age from 18-70 years old.
- Serum Uric Acid level 7.0 mg/dL or more.
- Stable clinical condition (no hospitalization in the previous 3 months)
- Informed consent in accordance with the Declaration of Helsinki.
Who cannot join
- Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
- History of hypersensitivity to febuxostat.
- Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician
About this study
Official title: Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients.
Read the detailed description
Aim of The Work:
1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of:
- Primary endpoint:
- Reduction in Asymmetrical Dimethylarginine (ADMA)
- Secondary endpoints:
- Assessing the change in serum High sensitivity C-reactive protein (hsCRP)
- Assessing the change in serum Uric acid - The criteria for inclusion:
- Outpatients on maintenance hemodialysis.
- Age from 18-70 years old.
- Serum UA level 7.0 mg/dL or more.
- Stable clinical condition (no hospitalization in the previous 3 months)
The exclusion criteria:
- Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
- History of hypersensitivity to febuxostat.
- Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician.
After two months , the patient will be reassessed regarding:
- ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.
- Conditions
- Endothelial Dysfunction, Endstage Renal Disease
- Being tested
- Febuxostat, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
Also called Donifoxate
Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session
PlaceboDrug
Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session.
same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | This Group of Patients will receive Febuxostat Drug along with their Standard Treatment. Receives: Drug: Febuxostat |
| Group II | Placebo comparator | This Group of Patients will receive Placebo along with their standard Treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetric Dimethylarginine physiological marker
Asymmetric dimethylarginine (ADMA) physiological marker for assessing endothelial dysfunction will be measured for all the anticipated 50 patients at time zero and by the end of the two months.
Measured: 2 months
Secondary outcomes (2)
Uric Acid , physiological parameter
Uric acid,physiological parameter for assessing the grade of hyperuricemia will be measured for all the anticipated 50 patients at time zero and by the end of the two months.
Measured: 2 months
High sensitivity C-reactive protein physiological marker
HsCRP , physiological marker for assessing inflammation will be measured for all the anticipated 50 patients at time zero and by the end of the two months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona AlShahawey AlSayed Ghazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866214
- Sponsor's protocol ID
- phCL 35
- Status last verified
- Dec 2017
- First submitted
- 10 Aug 2016
- Last updated
- 2 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT02866214
- Acronym / sponsor ID
- phCL 35
- Conditions
- Endothelial Dysfunction, Endstage Renal Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Aug 2016 (estimated)
- 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.
The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients.
Detailed description
Aim of The Work:
1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of:
- Primary endpoint:
- Reduction in Asymmetrical Dimethylarginine (ADMA)
- Secondary endpoints:
- Assessing the change in serum High sensitivity C-reactive protein (hsCRP)
- Assessing the change in serum Uric acid - The criteria for inclusion:
- Outpatients on maintenance hemodialysis.
- Age from 18-70 years old.
- Serum UA level 7.0 mg/dL or more.
- Stable clinical condition (no hospitalization in the previous 3 months)
The exclusion criteria:
- Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
- History of hypersensitivity to febuxostat.
- Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician.
After two months , the patient will be reassessed regarding:
- ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: FebuxostatThis Group of Patients will receive Febuxostat Drug along with their Standard Treatment. |
| Group II | Placebo comparator | Drug: PlaceboThis Group of Patients will receive Placebo along with their standard Treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients on maintenance hemodialysis.
- Age from 18-70 years old.
- Serum Uric Acid level 7.0 mg/dL or more.
- Stable clinical condition (no hospitalization in the previous 3 months)
- Informed consent in accordance with the Declaration of Helsinki.
Key exclusion criteria (5 listed)
- Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
- History of hypersensitivity to febuxostat.
- Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician
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 |
|---|---|---|
| FebuxostatAlso: DonifoxateFilm Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session | Drug | Group I |
| PlaceboFilm Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) . | Drug | Group II |
Primary outcome
Asymmetric Dimethylarginine physiological marker
Time frame: 2 months
Asymmetric dimethylarginine (ADMA) physiological marker for assessing endothelial dysfunction will be measured for all the anticipated 50 patients at time zero and by the end of the two months.
2 secondary outcomes
Uric Acid , physiological parameter
Time frame: 2 months
High sensitivity C-reactive protein physiological marker
Time frame: 2 months
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 2 Jan 2018.
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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 Phase 2/3 study testing Febuxostat in people with Endothelial Dysfunction and Endstage Renal Disease, run by Ain Shams 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 5 inclusion and 5 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 2 Jan 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Asymmetric Dimethylarginine physiological marker (time frame: 2 months). 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 2 Jan 2018.