End Stage Renal Disease on DialysisHome-BPNCT05159999
The Home Blood Pressure (BP) Trial
A study testing Dry weight target adjustment and Anti-hypertensive medications in people with End Stage Renal Disease on Dialysis, run by University of Washington at 2 sites in United States.
Trial summary
The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Dry weight target adjustment and Anti-hypertensive medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2022to 1 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD)
- Greater than 3 months since initiation of dialysis
- No anticipated change to peritoneal dialysis or kidney transplant within 10 months
- Life expectancy greater than 10 months
- Hypertension (defined as mean pre-dialysis SBP > 140 mmHg over prior 2 weeks or taking BP medications)
- Able to obtain/measure a brachial blood pressure at dialysis and at home (e.g., no left ventricular assist device, blood pressure not been taken routinely in lower extremity at dialysis unit)
- No condition that the primary nephrologist or PIs feel precludes participation
Who cannot join
- Incarcerated or institutionalized (prohibits home blood pressure measurement)
- Participating in another intervention study that may affect blood pressure
- Pregnant or anticipated pregnancy or breastfeeding (as this will require increase to more than three times a week dialysis and/or preclude use of some classes of blood pressure medications)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98104
About this study
The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of <140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.
Read the detailed description
The main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg in reducing rates of intradialytic hypotension. The target systolic blood pressure of 100-140 mmHg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. Home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Dry weight target adjustment, Anti-hypertensive medications
- Keywords
- Blood pressure, dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry weight target adjustmentOther
Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target.
Anti-hypertensive medicationsDrug
Anti-hypertensive medications will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. Adjustment of currently prescribed anti-hypertensive medications will be prioritized before starting new medications. Only standard anti-hypertensive medications will be used, such as RAAS inhibitors, beta-blockers, calcium channel blockers and diuretics.
| Study group | Role | What they receive |
|---|---|---|
| Home Systolic Blood Pressure <140 mmHg | Experimental | Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <140 mmHg. Receives: Other: Dry weight target adjustment; Drug: Anti-hypertensive medications |
| Pre-Dialysis Systolic Blood Pressure <140 mmHg | Active comparator | Participants will have their blood pressure taken by an automated blood pressure device by dialysis unit staff using regular dialysis unit equipment according to usual clinical care. Pre-dialysis blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a pre-dialysis systolic blood pressure target of <140 mmHg. Receives: Other: Dry weight target adjustment; Drug: Anti-hypertensive medications |
| Home Systolic Blood Pressure <130 mmHg | Other | This will be an optional, exploratory 2 month study at the end of the primary 10-month trial. Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <130 mmHg. Receives: Other: Dry weight target adjustment; Drug: Anti-hypertensive medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of IDH
Measured: 10 months
Secondary outcomes (3)
Fatigue by SONG-HD Score
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on patient reported fatigue, as ascertained by the SONG-HD Fatigue Score (PMID: 33093215)
Measured: 10 months
Cramping
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on frequency of cramping
Measured: 10 months
Rates of hospitalizations for cardiovascular events and volume overload
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of hospitalizations for cardiovascular events and volume overload
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start2 Feb 2022
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
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 on DialysisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Nisha Bansal, University of Washington
- Investigators
- Nisha Bansal, MD, Principal investigator, University of WashingtonChi-yuan Hsu, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159999
- Sponsor's protocol ID
- STUDY00012367
- Other IDs
- R01DK123104
- Acronym
- Home-BP
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2021
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Home Blood Pressure (BP) Trial
- ClinicalTrials.gov ID
- NCT05159999
- Acronym / sponsor ID
- Home-BP / STUDY00012367
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Blood pressure, dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 16 Dec 2021 (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 main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of <140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.
Detailed description
The main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg in reducing rates of intradialytic hypotension. The target systolic blood pressure of 100-140 mmHg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. Home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Systolic Blood Pressure <140 mmHg | Experimental | Other: Dry weight target adjustment, Drug: Anti-hypertensive medicationsParticipants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <140 mmHg. |
| Pre-Dialysis Systolic Blood Pressure <140 mmHg | Active comparator | Other: Dry weight target adjustment, Drug: Anti-hypertensive medicationsParticipants will have their blood pressure taken by an automated blood pressure device by dialysis unit staff using regular dialysis unit equipment according to usual clinical care. Pre-dialysis blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a pre-dialysis systolic blood pressure target of <140 mmHg. |
| Home Systolic Blood Pressure <130 mmHg | Other | Other: Dry weight target adjustment, Drug: Anti-hypertensive medicationsThis will be an optional, exploratory 2 month study at the end of the primary 10-month trial. Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <130 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older
- Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD)
- Greater than 3 months since initiation of dialysis
- No anticipated change to peritoneal dialysis or kidney transplant within 10 months
- Life expectancy greater than 10 months
Key exclusion criteria (3 listed)
- Incarcerated or institutionalized (prohibits home blood pressure measurement)
- Participating in another intervention study that may affect blood pressure
- Pregnant or anticipated pregnancy or breastfeeding (as this will require increase to more than three times a week dialysis and/or preclude use of some classes of blood pressure medications)
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 |
|---|---|---|
| Dry weight target adjustmentTarget dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. | Other | Home Systolic Blood Pressure <130 mmHg, Home Systolic Blood Pressure <140 mmHg, Pre-Dialysis Systolic Blood Pressure <140 mmHg |
| Anti-hypertensive medicationsAnti-hypertensive medications will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. Adjustment of currently prescribed anti-hypertensive medications will be prioritized before starting new medications. Only standard anti-hypertensive medications will be used, such as RAAS inhibitors, beta-blockers, calcium channel blockers and diuretics. | Drug | Home Systolic Blood Pressure <130 mmHg, Home Systolic Blood Pressure <140 mmHg, Pre-Dialysis Systolic Blood Pressure <140 mmHg |
Primary outcome
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
Time frame: 10 months
Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of IDH
3 secondary outcomes
Fatigue by SONG-HD Score
Time frame: 10 months
Cramping
Time frame: 10 months
Rates of hospitalizations for cardiovascular events and volume overload
Time frame: 10 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 20 Jul 2026.
- 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.
Nisha Bansal, MD principal investigator
University of Washington
Chi-yuan Hsu, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry weight target adjustment and Anti-hypertensive medications in people with End Stage Renal Disease on Dialysis, run by University of Washington at 2 sites in United States.
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 8 inclusion and 3 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis (time frame: 10 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 20 Jul 2026.