HemodialysisNCT05771350
Online Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients
A study testing online hemodiafiltration, high flux hemodialysis and low flux hemodialysis in people with Hemodialysis, run by Ain Shams University.
Trial summary
this study aimed to compare the removal of indoxyl sulphate between hemodiafiltration, high flux hemodialysis and low flux hemodialysis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- online hemodiafiltration, high flux hemodialysis and low flux hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2016to 15 Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- maintenance hemodialysis patients aged more than 18 years
Who cannot join
- active illnesses, hospitalization, malignancy
About this study
Official title: Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients
this study aimed to compare the removal of indoxyl sulphate between hemodiafiltration, high flux hemodialysis and low flux hemodialysis
- Conditions
- Hemodialysis
- Being tested
- online hemodiafiltration, high flux hemodialysis, low flux hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online hemodiafiltrationProcedure or surgery
20 patients on regular hemodialysis received online hemodiafiltration
high flux hemodialysisProcedure or surgery
20 patients on regular hemodialysis received high flux hemodialysis
low flux hemodialysisProcedure or surgery
20 patients on regular hemodialysis received low flux hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| online hemodiafiltration | Experimental | Not described Receives: Procedure: online hemodiafiltration |
| high flux hemodialysis | Active comparator | Not described Receives: Procedure: high flux hemodialysis |
| low flux hemodialysis | Active comparator | Not described Receives: Procedure: low flux hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
dialytic removal of indoxyl sulpahte
assessed by the reduction ration of indoxyl sulphate
Measured: one month when all samples were collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start15 Nov 2016
- Primary completion15 Jan 2017
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed sary gharib, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771350
- Sponsor's protocol ID
- FMASU MD 301/2016
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05771350
- Acronym / sponsor ID
- FMASU MD 301/2016
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 16 Mar 2023 (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.
this study aimed to compare the removal of indoxyl sulphate between hemodiafiltration, high flux hemodialysis and low flux hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| online hemodiafiltration | Experimental | Procedure: online hemodiafiltration |
| high flux hemodialysis | Active comparator | Procedure: high flux hemodialysis |
| low flux hemodialysis | Active comparator | Procedure: low flux hemodialysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- maintenance hemodialysis patients aged more than 18 years
Key exclusion criteria (1 listed)
- active illnesses, hospitalization, malignancy
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 |
|---|---|---|
| online hemodiafiltration20 patients on regular hemodialysis received online hemodiafiltration | Procedure or surgery | online hemodiafiltration |
| high flux hemodialysis20 patients on regular hemodialysis received high flux hemodialysis | Procedure or surgery | high flux hemodialysis |
| low flux hemodialysis20 patients on regular hemodialysis received low flux hemodialysis | Procedure or surgery | low flux hemodialysis |
Primary outcome
dialytic removal of indoxyl sulpahte
Time frame: one month when all samples were collected
assessed by the reduction ration of indoxyl sulphate
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 16 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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 online hemodiafiltration, high flux hemodialysis and low flux hemodialysis in people with Hemodialysis, 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 1 inclusion and 1 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 16 Mar 2023. 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?
dialytic removal of indoxyl sulpahte (time frame: one month when all samples were collected). 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 16 Mar 2023.