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RecruitingNCT07144332Updated Aug 27, 2025

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 in Hemodialysis and Hyperuricemia, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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 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

  1. Type of The study:

    Prospective cross-sectional study.

  2. Place of the study:

    Sohag University Hospital, department of Internal Medicine and hemodialysis unit.

  3. 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:

  1. Gender.
  2. Age.
  3. Underlying nephropathy.
  4. Average time on renal replacement therapy.
  5. Comorbidities,
  6. Residual renal function (\< 100 ml/24 or ≥ 100 ml/24 h) of participants.
  7. Current hemodialysis session parameters such as vascular access.
  8. Duration of the session.
  9. Time interval between the current and previous dialysis session.
  10. Body mass index (BMI).
  11. Blood pressure at the beginning and at the end of dialysis
  12. Dialysis adequacy.
  13. Blood flow (\< 300ml/min or>300ml/min).
  14. 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.
02

Conditions studied

  • Hemodialysis
  • Hyperuricemia

Keywords

  • Hemodialysis
  • Hyperuricemia
  • chronic kidney disease
03

In context

Hyperuricemia

240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.

This study's planned enrollment of 100 is below the median of 183 across 40 observational studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hemodialysis patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Patients aged \< 18 years old .
  2. Patients on recent hemodialysis less than 3 months.
  3. We excluded patients who were on Uric acid lowering therapy (UALT).
  4. Patients received less than 4 hours of hemodialysis and those who had emergency dialysis.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. study of serum uric acid level in hemodialysis patients

    milligrams per deciliter (mg/dL)

    Time frame: during hemodialysis session 2 to 3 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Dec 2025, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2025
First posted
Aug 27, 2025
StartActual
Jul 13, 2025
Primary completionEst.
Dec 29, 2025
CompletionEst.
Feb 1, 2026
Last update
Aug 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07144332
Lead sponsor
Sohag University
Responsible party
Reham Hussien Abotaleb (Internal medicine resident doctor, Sohag University) — Principal investigator
First posted
Aug 27, 2025
Start date
Jul 13, 2025
Primary completion
Dec 29, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Aug 27, 2025

Study contacts

Reham Hussien, master
Contact
rehamhussien1937@yahoo.com
00201092162739
Ali taha, Professor
Contact
00201005871047

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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