Hypertension in Dialysis PatientsPhase 2/3NCT07231900
Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients
A Phase 2/3 study testing Sodium Bicarbonate (NaHCO3) in people with Hypertension in Dialysis Patients, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The study is designed to diminish intra-dialytic hypertension in chrnic hemodialysis patients suffering from metabolic acidosis (low bicarbonate levels). The intervention is a tab of 500 mg sodium bicarbonate twice a day for one month, vs. placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension in Dialysis Patients
- What is being tested?
- Sodium Bicarbonate (NaHCO3)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Nov 2025to 1 Dec 2027
- Phase
- Phase 2/3
- 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
Who may be able to join
- Chronic hemodialysis patient > 3 months
- 3 dialysis per week, KTV>1.2
- capable of informed concent.
- rise in blood pressure during hemodialysis > 10 mm Hg, for at least 50% of dialysis sessions in the month prior to inclusion.
- Normal volume status, by clinical physician assessment + bioimpedance
Who cannot join
- age under 18,
- pregnancy
- unable to sign informed concent
- planned for kidney transplant in the following 3 month.
- congestive heart failure (NYHA 3-4)
- hospitalization for acute MI or CHF in the past 3 months.
- low compliece to medical therapy
- regular pre-dialysis tests with bicarbonate > 24 in the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The study is designed to diminish intra-dialytic hypertension in chrnic hemodialysis patients suffering from metabolic acidosis (low bicarbonate levels). The intervention is a tab of 500 mg sodium bicarbonate twice a day for one month, vs. placebo.
- Conditions
- Hypertension in Dialysis Patients
- Being tested
- Sodium Bicarbonate (NaHCO3), Placebo
- Keywords
- Intra-dialytic hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate (NaHCO3)Drug
Prescribing Sodium Bicaronate for intra-dualytic hypertension
PlaceboDrug
1 tab X 2/day
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | PO Sodium bicarbonate 500mg X2/day Receives: Drug: Sodium Bicarbonate (NaHCO3) |
| Placebo | Placebo comparator | 1 tab X2/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Prevention of intra dialytic hypertension
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start10 Nov 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in Dialysis PatientsStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shani Zilberman Itskovich, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231900
- Sponsor's protocol ID
- 0208-25-ASF
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: blood pressure results, blood tests
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07231900
- Acronym / sponsor ID
- 0208-25-ASF
- Conditions
- Hypertension in Dialysis Patients
- Keywords
- Intra-dialytic hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Nov 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.
The study is designed to diminish intra-dialytic hypertension in chrnic hemodialysis patients suffering from metabolic acidosis (low bicarbonate levels). The intervention is a tab of 500 mg sodium bicarbonate twice a day for one month, vs. placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium Bicarbonate (NaHCO3)PO Sodium bicarbonate 500mg X2/day |
| Placebo | Placebo comparator | Drug: Placebo1 tab X2/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic hemodialysis patient > 3 months
- 3 dialysis per week, KTV>1.2
- capable of informed concent.
- rise in blood pressure during hemodialysis > 10 mm Hg, for at least 50% of dialysis sessions in the month prior to inclusion.
- Normal volume status, by clinical physician assessment + bioimpedance
Key exclusion criteria (8 listed)
- age under 18,
- pregnancy
- unable to sign informed concent
- planned for kidney transplant in the following 3 month.
- congestive heart failure (NYHA 3-4)
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 |
|---|---|---|
| Sodium Bicarbonate (NaHCO3)Prescribing Sodium Bicaronate for intra-dualytic hypertension | Drug | Sodium bicarbonate |
| Placebo1 tab X 2/day | Drug | Placebo |
Primary outcome
Blood pressure
Time frame: 1 month
Prevention of intra dialytic hypertension
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 17 Nov 2025.
- Individual participant dataSharing planned: Yes. blood pressure results, blood tests
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium Bicarbonate (NaHCO3) in people with Hypertension in Dialysis Patients, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 8 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: opening soon, as of the sponsor's last update on 17 Nov 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 Israel. 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. 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?
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 Shani Zilberman Itskovich, Dr. (+97289779383, shani.zilberman@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 1 month). 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 17 Nov 2025.