HemodialysisNCT07144332
This Study is to Estimate the Efficacy of Hemodialysis Alone for Uric Acid Clearance in Patients on Hemodialysis. In Order to Evaluate the Need of Adjuvant Uric Acid Lowering Therapy
An observational study of Hemodialysis and Hyperuricemia, run by Sohag University at 1 site in Egypt.
Trial summary
Background: Uricemia dramatically rises with the stage of chronic kidney disease (CKD) and correlates with its mortality. Hemodialysis (HD) being the most used treatment at the end stage kidney disease in Sohag governorate , we sought to evaluate its efficacy on the clearance of uric acid (UAc) when used alone and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Hyperuricemia
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients
Who may be able to join
- We included all consenting adults aged 18 or older, on maintenance hemodialysis for at least 3 consecutive months receiving 2 to 3 sessions weekly
Who cannot join
- Patients aged < 18 years old .
- Patients on recent hemodialysis less than 3 months.
- We excluded patients who were on Uric acid lowering therapy (UALT).
- Patients received less than 4 hours of hemodialysis and those who had emergency dialysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali taha, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university faculty of medicine
Sohag
Magdy M Amin, Professor
About this study
Official title: Assessment of the Efficacy of Hemodialysis on Uric Acid Clearance at End Stage Kidney Disease in Sohag University Hospital
Background: Uricemia dramatically rises with the stage of chronic kidney disease (CKD) and correlates with its mortality. Hemodialysis (HD) being the most used treatment at the end stage kidney disease in Sohag governorate , we sought to evaluate its efficacy on the clearance of uric acid (UAc) when used alone and twice per week.
Methods: A cross-sectional study of all consenting patients with CKD stage 5 recruited at random during hemodialysis sessions at hemodialysis unit in Sohag university hospital from July to December 2025. We collected socio-demographic data, relevant clinical information, hemodialysis related variables, and measured serum uric acid (SUA) levels before and after the dialysis to assess the uric acid clearance. A clearance between 65 and 80% and above 80% was considered as low and good efficacy of hemodialysis respectively
Read the detailed description
Aim of the the work The aim of this study is to estimate the efficacy of Hemodialysis alone for uric acid clearance in patients on hemodialysis. In order to evaluate the need of adjuvant uric acid lowering therapy
Patients And Methods
- Type of The study: Prospective cross-sectional study.
- Place of the study: Sohag University Hospital, department of Internal Medicine and hemodialysis unit.
- Ethical aspect:
Informed Written consent will be taken from all patients to include their data in the study, the research will be approved by medical ethics committee of Faculty of Medicine, Sohag university
Patients:
Inclusion criteria:
- We included all consenting adults aged 18 or older, on maintenance hemodialysis for at least 3 consecutive months receiving 2 to 3 sessions weekly.
Exclusion criteria:
- Patients aged < 18 years old .
- Patients on recent hemodialysis less than 3 months.
- We excluded patients who were on Uric acid lowering therapy (UALT).
- Patients received less than 4 hours of hemodialysis and those who had emergency dialysis.
Number of Patients:
The study will include 100 hemodialysis patients for duration of 6 months.
- Methods We carried out a prospective cross-sectional study at the Hemodialysis unit in Sohag University Hospital . Patients included in the study dialyzed with the Fresenius® 4008S generator (Fresenius Medical Care, St. Wendel, Germany) dialyzers , with a polysulfone synthetic dialysis membrane and bicarbonate dialysate.
The size of the dialysis membrane was estimated according to the total body surface of the patient . Membranes sizes FX60 were used for a body surface of approximately (1.2-1.5 m2 ) ; whereas FX80 between (1.6 and 1.8m2 ) and FX100 were used for body surfaces above 1.8m2.
Dialysis adequacy was calculated from the formula Kt/ V urea; K being the clearance of urea given by the dialyzer, t the duration of the dialysis session (4 h) and V the distribution volume of urea [10].
Uric acid clearance (UAc) was estimated using the formula: UAc=100 x (SUA levels before HD-SUA levels after HD) / SUA levels before HD] [14]. We defined two thresholds values for UAc (65 and 80%).
A Hemodialysis session was considered to be of low efficacy if below 65% of reduction, moderate efficacy between 65 and 80% and a good efficacy above 80% of UAc . [15].
These predictors will be included:
- Gender.
- Age.
- Underlying nephropathy.
- Average time on renal replacement therapy.
- Comorbidities,
- Residual renal function (< 100 ml/24 or ≥ 100 ml/24 h) of participants.
- Current hemodialysis session parameters such as vascular access.
- Duration of the session.
- Time interval between the current and previous dialysis session.
- Body mass index (BMI).
- Blood pressure at the beginning and at the end of dialysis
- Dialysis adequacy.
- Blood flow (< 300ml/min or>300ml/min).
- Serum uric acid level which were assessed on a peripheral blood sample collected 5 min before and after dialysis.
Statistical analysis
- All collected data will be analyzed and correlated.
- All the statistical analysis will be done by using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL) version20.
- Baseline data and patient characteristics will be presented using descriptive statistics, for example, number, percentage, mean and standard deviation.
- Conditions
- Hemodialysis, Hyperuricemia
- Keywords
- Hemodialysis, Hyperuricemia, chronic kidney disease
- Medical subject headings
- Hyperuricemia, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
study of serum uric acid level in hemodialysis patients
milligrams per deciliter (mg/dL)
Measured: during hemodialysis session 2 to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start13 Jul 2025
- Primary completion29 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
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 Sohag 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Hussien Abotaleb, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144332
- Sponsor's protocol ID
- Soh-Med-25-7-13MS
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Hemodialysis on Uric Acid Clearance at End Stage Kidney Disease in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT07144332
- Acronym / sponsor ID
- Soh-Med-25-7-13MS
- Conditions
- Hemodialysis, Hyperuricemia
- Keywords
- Hemodialysis, Hyperuricemia, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 29 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 27 Aug 2025 (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.
Background: Uricemia dramatically rises with the stage of chronic kidney disease (CKD) and correlates with its mortality. Hemodialysis (HD) being the most used treatment at the end stage kidney disease in Sohag governorate , we sought to evaluate its efficacy on the clearance of uric acid (UAc) when used alone and twice per week.
Methods: A cross-sectional study of all consenting patients with CKD stage 5 recruited at random during hemodialysis sessions at hemodialysis unit in Sohag university hospital from July to December 2025. We collected socio-demographic data, relevant clinical information, hemodialysis related variables, and measured serum uric acid (SUA) levels before and after the dialysis to assess the uric acid clearance. A clearance between 65 and 80% and above 80% was considered as low and good efficacy of hemodialysis respectively
Detailed description
Aim of the the work The aim of this study is to estimate the efficacy of Hemodialysis alone for uric acid clearance in patients on hemodialysis. In order to evaluate the need of adjuvant uric acid lowering therapy
Patients And Methods
- Type of The study: Prospective cross-sectional study.
- Place of the study: Sohag University Hospital, department of Internal Medicine and hemodialysis unit.
- Ethical aspect:
Informed Written consent will be taken from all patients to include their data in the study, the research will be approved by medical ethics committee of Faculty of Medicine, Sohag university
Patients:
Inclusion criteria:
- We included all consenting adults aged 18 or older, on maintenance hemodialysis for at least 3 consecutive months receiving 2 to 3 sessions weekly.
Exclusion criteria:
- Patients aged < 18 years old .
- Patients on recent hemodialysis less than 3 months.
- We excluded patients who were on Uric acid lowering therapy (UALT).
- Patients received less than 4 hours of hemodialysis and those who had emergency dialysis.
Number of Patients:
The study will include 100 hemodialysis patients for duration of 6 months.
- Methods We carried out a prospective cross-sectional study at the Hemodialysis unit in Sohag University Hospital . Patients included in the study dialyzed with the Fresenius® 4008S generator (Fresenius Medical Care, St. Wendel, Germany) dialyzers , with a polysulfone synthetic dialysis membrane and bicarbonate dialysate.
The size of the dialysis membrane was estimated according to the total body surface of the patient . Membranes sizes FX60 were used for a body surface of approximately (1.2-1.5 m2 ) ; whereas FX80 between (1.6 and 1.8m2 ) and FX100 were used for body surfaces above 1.8m2.
Dialysis adequacy was calculated from the formula Kt/ V urea; K being the clearance of urea given by the dialyzer, t the duration of the dialysis session (4 h) and V the distribution volume of urea [10].
Uric acid clearance (UAc) was estimated using the formula: UAc=100 x (SUA levels before HD-SUA levels after HD) / SUA levels before HD] [14]. We defined two thresholds values for UAc (65 and 80%).
A Hemodialysis session was considered to be of low efficacy if below 65% of reduction, moderate efficacy between 65 and 80% and a good efficacy above 80% of UAc . [15].
These predictors will be included:
- Gender.
- Age.
- Underlying nephropathy.
- Average time on renal replacement therapy.
- Comorbidities,
- Residual renal function (< 100 ml/24 or ≥ 100 ml/24 h) of participants.
- Current hemodialysis session parameters such as vascular access.
- Duration of the session.
- Time interval between the current and previous dialysis session.
- Body mass index (BMI).
- Blood pressure at the beginning and at the end of dialysis
- Dialysis adequacy.
- Blood flow (< 300ml/min or>300ml/min).
- Serum uric acid level which were assessed on a peripheral blood sample collected 5 min before and after dialysis.
Statistical analysis
- All collected data will be analyzed and correlated.
- All the statistical analysis will be done by using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL) version20.
- Baseline data and patient characteristics will be presented using descriptive statistics, for example, number, percentage, mean and standard deviation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients
Key inclusion criteria (1 listed)
- We included all consenting adults aged 18 or older, on maintenance hemodialysis for at least 3 consecutive months receiving 2 to 3 sessions weekly
Key exclusion criteria (4 listed)
- Patients aged < 18 years old .
- Patients on recent hemodialysis less than 3 months.
- We excluded patients who were on Uric acid lowering therapy (UALT).
- Patients received less than 4 hours of hemodialysis and those who had emergency dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
study of serum uric acid level in hemodialysis patients
Time frame: during hemodialysis session 2 to 3 hours
milligrams per deciliter (mg/dL)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- 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.
Ali taha, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis and Hyperuricemia, run by Sohag University at 1 site in Egypt.
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 4 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reham Hussien, master (00201092162739, rehamhussien1937@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study of serum uric acid level in hemodialysis patients (time frame: during hemodialysis session 2 to 3 hours). 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 27 Aug 2025.