End Stage Renal Disease (ESRD)Phase 1NCT07765459
the Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Hemodialysis Patients
A Phase 1 study testing Oral sodium bicarbonate in people with End Stage Renal Disease (ESRD) and Metabolic Acidosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), Metabolic Acidosis
- What is being tested?
- Oral sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 29 Feb 2024
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult prevalent hemodialysis patients (age 18 years or older) On regular hemodialysis for more than 6 months, with three sessions per week, each lasting four hours Metabolic acidosis at the time of recruitment, defined as a serum bicarbonate level ≤22 mmol/L for at least 6 months before the study
Who cannot join
- Patients with hemodialysis catheters Active inflammation, infection, or active malignancy History of parathyroidectomy Other organ failure, such as decompensated heart failure or liver failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Prevalent Hemodialysis Patients
the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients
Read the detailed description
- Type of Study: Prospective randomized interventional study using simple randomization ( even and odd number method )
- Study Settings: Ain Shams University hospital hemodialysis unit , Cairo, Egypt.
- Study period: 6 months.
Inclusion Criteria:
- Adult prevalent hemodialysis patients on regular hemodialysis more than 6 months , three sessions per week of four hours duration
- Patients with metabolic acidosis at the time they were recruited with serum bicarbonate levels ≤22 mmol/l for at least 6 months before the study.
Exclusion Criteria: patients with the following will be excluded from the study
- Patients with hemodialysis catheters
- Patients with active inflammation , infection or active malignancy
- Patients with history of parathyroidectomy
- Patients with other organ failure such as decompensated heart failure or liver cell failure
- Study Population: Adult patients on regular hemodialysis with metabolic acidosis at the time they were recruited with serum bicarbonate levels ≤22 mmol/l for at least 6 months before the study.
- Sample size: 20 ESRD patients who had been on regular hemodialysis with serum bicarbonate levels ≤22 for at least 6 months 20 ESRD patients on regular hemodialysis with serum bicarbonate levels ≤22 for at least 6 months as control matched in age and sex all patients will be subjected to the following:
- Full history taking.
- General and local examination. C-Laboratory investigations . The following parameters will be assessed before and after correction of acidosis: total serum calcium, serum albumin , plasma phosphate, iPTH, serum bicarbonate concentration, hemoglobin,. parameters will be drawn at the start of the dialysis session after the long dialysis interval Patients will be studied both before (pre) and at the end of (post) 6 months of correction of their metabolic acidosis by oral supplementation with sodium bicarbonate mean dose 1-3 g/day . Serum bicarbonate levels during correction will be maintained between 22 and 28 mmol/l . serum bicarbonate level will be withdrawn monthly and if the patients Hco3 during the monthly follow up exceeds 28 mmol/l , the dose of sodium bicarbonate will be withheld and we will follow up the serum bicarbonate level one month later .
Imaging : carotid artery duplex will be done to all patients at the start of the study and at the end
Imaging : carotid artery duplex will be done to all patients at the start of the study and at the end
- Conditions
- End Stage Renal Disease (ESRD), Metabolic Acidosis
- Being tested
- Oral sodium bicarbonate
- Medical subject headings
- Kidney Failure, Chronic, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sodium bicarbonateDrug
oral sodium bicarbonate to correct interdialytic metabolic acidosis
| Study group | Role | What they receive |
|---|---|---|
| oral sodium bicarbonate | Active comparator | this group will receive oral sodium bicabonate daily Receives: Drug: Oral sodium bicarbonate |
| no intervention : control group | No intervention | participants in this arm will receive standard care without bicarbonate supplementation : they will serve as the control group for comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction of acidosis and its effect on vascular calcification
change in carotid intimal media thickness (CIMT ) , measured by B mode ultrasound of the common carotid artery , the unit is millimeters
Measured: 6 months
Secondary outcomes (7)
Change in Serum Calcium Level
Serum calcium will be measured from blood samples at baseline and at the end of the study. The change in serum calcium level from baseline to the end of the study will be assessed.Unit of Measure: mg/dL
Measured: 6 months
Change in Serum Phosphorus Level
Serum phosphorus will be measured from blood samples at baseline and at the end of the study. The change in serum phosphorus level from baseline to the end of the study will be assessed. Unit of Measure: mg/dL
Measured: 6 months
Change in Intact Parathyroid Hormone (iPTH) Level
Serum intact parathyroid hormone (iPTH) will be measured from blood samples at baseline and at the end of the study. The change in iPTH level from baseline to the end of the study will be assessed. Unit of Measure: pg/mL
Measured: 6 months
Change in Hemoglobin Concentration
Hemoglobin concentration will be measured from blood samples at baseline and at the end of the study. The change in hemoglobin concentration from baseline to the end of the study will be assessed . Unit of Measure: g/dL
Measured: 6 months
Change in Serum Albumin Level
Serum albumin will be measured from blood samples at baseline and at the end of the study. The change in serum albumin level from baseline to the end of the study will be assessed.
Measured: Unit of Measure: g/dL
Change in Venous Blood pH
Venous blood pH will be measured at baseline and at the end of the study. The change in venous blood pH from baseline to the end of the study will be assessed. Unit of Measure: pH units
Measured: 6 months
Change in Serum Bicarbonate Level
Serum bicarbonate will be measured from blood samples at baseline and at the end of the study. The change in serum bicarbonate level from baseline to the end of the study will be assessed. Unit of Measure: mmol/L
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Sep 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abubakr mohamed fahmy, assistant lecturer, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765459
- Sponsor's protocol ID
- FMASU MD190/2023
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Prevalent Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07765459
- Acronym / sponsor ID
- FMASU MD190/2023
- Conditions
- End Stage Renal Disease (ESRD), Metabolic Acidosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 14 Aug 2026 (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.
the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients
Detailed description
- Type of Study: Prospective randomized interventional study using simple randomization ( even and odd number method )
- Study Settings: Ain Shams University hospital hemodialysis unit , Cairo, Egypt.
- Study period: 6 months.
Inclusion Criteria:
- Adult prevalent hemodialysis patients on regular hemodialysis more than 6 months , three sessions per week of four hours duration
- Patients with metabolic acidosis at the time they were recruited with serum bicarbonate levels ≤22 mmol/l for at least 6 months before the study.
Exclusion Criteria: patients with the following will be excluded from the study
- Patients with hemodialysis catheters
- Patients with active inflammation , infection or active malignancy
- Patients with history of parathyroidectomy
- Patients with other organ failure such as decompensated heart failure or liver cell failure
- Study Population: Adult patients on regular hemodialysis with metabolic acidosis at the time they were recruited with serum bicarbonate levels ≤22 mmol/l for at least 6 months before the study.
- Sample size: 20 ESRD patients who had been on regular hemodialysis with serum bicarbonate levels ≤22 for at least 6 months 20 ESRD patients on regular hemodialysis with serum bicarbonate levels ≤22 for at least 6 months as control matched in age and sex all patients will be subjected to the following:
- Full history taking.
- General and local examination. C-Laboratory investigations . The following parameters will be assessed before and after correction of acidosis: total serum calcium, serum albumin , plasma phosphate, iPTH, serum bicarbonate concentration, hemoglobin,. parameters will be drawn at the start of the dialysis session after the long dialysis interval Patients will be studied both before (pre) and at the end of (post) 6 months of correction of their metabolic acidosis by oral supplementation with sodium bicarbonate mean dose 1-3 g/day . Serum bicarbonate levels during correction will be maintained between 22 and 28 mmol/l . serum bicarbonate level will be withdrawn monthly and if the patients Hco3 during the monthly follow up exceeds 28 mmol/l , the dose of sodium bicarbonate will be withheld and we will follow up the serum bicarbonate level one month later .
Imaging : carotid artery duplex will be done to all patients at the start of the study and at the end
Imaging : carotid artery duplex will be done to all patients at the start of the study and at the end
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral sodium bicarbonate | Active comparator | Drug: Oral sodium bicarbonatethis group will receive oral sodium bicabonate daily |
| no intervention : control group | No intervention | –participants in this arm will receive standard care without bicarbonate supplementation : they will serve as the control group for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult prevalent hemodialysis patients (age 18 years or older) On regular hemodialysis for more than 6 months, with three sessions per week, each lasting four hours Metabolic acidosis at the time of recruitment, defined as a serum bicarbonate level ≤22 mmol/L for at least 6 months before the study
Key exclusion criteria (1 listed)
- Patients with hemodialysis catheters Active inflammation, infection, or active malignancy History of parathyroidectomy Other organ failure, such as decompensated heart failure or liver failure
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 |
|---|---|---|
| Oral sodium bicarbonateoral sodium bicarbonate to correct interdialytic metabolic acidosis | Drug | oral sodium bicarbonate |
Primary outcome
correction of acidosis and its effect on vascular calcification
Time frame: 6 months
change in carotid intimal media thickness (CIMT ) , measured by B mode ultrasound of the common carotid artery , the unit is millimeters
7 secondary outcomes
Change in Serum Calcium Level
Time frame: 6 months
Change in Serum Phosphorus Level
Time frame: 6 months
Change in Intact Parathyroid Hormone (iPTH) Level
Time frame: 6 months
Change in Hemoglobin Concentration
Time frame: 6 months
Change in Serum Albumin Level
Time frame: Unit of Measure: g/dL
Change in Venous Blood pH
Time frame: 6 months
Change in Serum Bicarbonate Level
Time frame: 6 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 14 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for End Stage Renal Disease (ESRD)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Abubakr mohamed fahmy, assistant lecturer principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral sodium bicarbonate in people with End Stage Renal Disease (ESRD) and Metabolic Acidosis, run by Ain Shams 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 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 14 Aug 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
correction of acidosis and its effect on vascular calcification (time frame: 6 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 14 Aug 2026.