End Stage Kidney Disease (ESKD)GOAL-BPNCT07910773
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
A study testing Target systolic blood pressure <120 mmHg. and Target systolic blood pressure <140 mmHg in people with End Stage Kidney Disease (ESKD) and Hypertension (HTN), run by University of California, San Francisco at 3 sites in United States.
Trial summary
The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease (ESKD), Hypertension (HTN), Peritoneal Dialysis (PD)
- What is being tested?
- Target systolic blood pressure <120 mmHg. and Target systolic blood pressure <140 mmHg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Oct 2026to Jun 2027
- Phase
- Interventional
- 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
- Age ≥ 18 years.
- Undergoing regular PD for treatment of ESKD.
- On PD for ≥ 4 months. (We do not plan to enroll patients within the first 3 months of PD initiation because there can be large fluctuations in volume status and BP readings before patient coming into more of a steady state. We then require participants to have at least 1 month of BP data to allow calculation of an average pre-enrollment BP for screening for study entry.)
- Diagnosis of HTN defined as being on antihypertensive medications or having routine clinic SBP ≥ 140 mmHg averaged over prior one month to screening.
- Able to measure brachial BP.
Who cannot join
- Planned transplant or HD transition < 4.5 months (the duration of study).
- Estimated life expectancy < 4.5 months (also determined by asking the treating nephrologist).
- Participation in another clinical trial that may affect BP management.
- Pregnancy, anticipated pregnancy, or breastfeeding as this will limit the use of certain antihypertension medications in the study and pose additional risks to the patient and many pregnant patients are transitioned over to hemodialysis.
- Incarceration or institutionalized living which may prohibit measurement of home BP.
- Presence of a condition or abnormality that, in the opinion of the study team or treating nephrologist, would compromise the safety of the patient or the quality of the data.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Satellite Healthcare - Daly City
San Francisco, California, 94014
Kashvi Gupta, MD, MPH, 734-546-4545, kashvi.gupta@ucsf.edu
- Not yet recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Kashvi Gupta, MD, MPH, 734-546-4545, kashvi.gupta@ucsf.edu
- Recruiting
Satellite Healthcare - San Francisco Geary
San Francisco, California, 94118
Kashvi Gupta, MD, MPH, 734-546-4545, kashvi.gupta@ucsf.edu
About this study
The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study.
Researchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future.
Read more
Participants will:
- Be assigned by chance to one of the two blood pressure goals.
- Have their blood pressure measured at clinic visits about every two weeks.
- Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal.
- Be part of the study for about four and a half months.
Read the detailed description
Peritoneal dialysis (PD) use among patients with end-stage kidney disease (ESKD) has increased substantially over the last decade. Yet there are no randomized clinical trials evaluating blood pressure (BP) targets in patients receiving PD.
GOAL-BP is a pilot study that will evaluate the feasibility of enrolling patients receiving PD to two systolic blood pressure targets (SBP): <120mmHg vs. <140 mmHg.
BP management will be guided by standardized clinic measurements. The study team will make recommendations to the treating nephrologist to achieve the goal SBP using a stepwise approach that addresses volume status before recommending changes to antihypertensive medications. The treating nephrologist will make the final decision about any changes to clinical care.
- Being tested
- Target systolic blood pressure <120 mmHg., Target systolic blood pressure <140 mmHg
- Keywords
- Target blood pressure, Peritoneal dialysis, End stage kidney disease, Hypertension
- Medical subject headings
- Kidney Failure, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target systolic blood pressure <120 mmHg.Other
The target SBP <120 mmHg will be operationalized as SBP 100-119 mmHg in the intervention arm.
For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics.
Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain SBP <120 mmHg in the interventional arm.
If SBP were <100 mmHg at one visit or <105 mmHg at two consecutive visits, BP medications will be reduced to keep SBP in the range of 100 to 119 mmHg, to avoid hypotensive episodes.
Target systolic blood pressure <140 mmHgOther
The target SBP <140 mmHg will be operationalized as SBP 130-139 mmHg. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain <140 mmHg in the control arm. If SBP were <130 mmHg at one visit or <135 mmHg at two consecutive visits, BP medications will be tapered/discontinued to keep SBP in the range of 130 to 139 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Target systolic blood pressure <120 mmHg Receives: Other: Target systolic blood pressure <120 mmHg. |
| Control | Other | Target systolic blood pressure <140 mmHg Receives: Other: Target systolic blood pressure <140 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of enrolling participants
The primary feasibility endpoint is the screen-to-enrollment ratio, calculated as the number of participants randomized divided by the number of potentially eligible individuals screened during the recruitment period. Physician refusal and patient refusal rates will also be reported.
Measured: 4.5 months
Secondary outcomes (6)
Retention of study participants
The duration a study participant will be in the study, from the baseline visit.
Measured: 4.5 months
Physician adherence to protocol recommendations for achieving target SBP
Measured: 4.5 months
Patient adherence to home BP measurements and recommended adjustments in dialysis prescription and medications
Adherence will be assessed by the number of times a patient follows the recommendations across BP measurements, changes in dialysis prescription, and medications.
Measured: 4.5 months
SBP achieved in each arm
Measured: 4.5 months
Change in residual kidney function under two different SBP targets
Residual kidney function is assessed by 24-hour urine collection as per the dialysis unit protocol and indication. These will be assessed to determine any changes.
Measured: 4.5 months
Safety of targeting SBP <120 mmHg vs. <140 mmHg
Measured: 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-yuan Hsu, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910773
- Sponsor's protocol ID
- STUDY00000009
- Acronym
- GOAL-BP
- Status last verified
- Nov 2026
- First submitted
- 28 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
- ClinicalTrials.gov ID
- NCT07910773
- Acronym / sponsor ID
- GOAL-BP / STUDY00000009
- Keywords
- Target blood pressure, Peritoneal dialysis, End stage kidney disease, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Nov 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 GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study.
Researchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future.
Participants will:
- Be assigned by chance to one of the two blood pressure goals.
- Have their blood pressure measured at clinic visits about every two weeks.
- Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal.
- Be part of the study for about four and a half months.
Detailed description
Peritoneal dialysis (PD) use among patients with end-stage kidney disease (ESKD) has increased substantially over the last decade. Yet there are no randomized clinical trials evaluating blood pressure (BP) targets in patients receiving PD.
GOAL-BP is a pilot study that will evaluate the feasibility of enrolling patients receiving PD to two systolic blood pressure targets (SBP): <120mmHg vs. <140 mmHg.
BP management will be guided by standardized clinic measurements. The study team will make recommendations to the treating nephrologist to achieve the goal SBP using a stepwise approach that addresses volume status before recommending changes to antihypertensive medications. The treating nephrologist will make the final decision about any changes to clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Target systolic blood pressure <120 mmHg.Target systolic blood pressure <120 mmHg |
| Control | Other | Other: Target systolic blood pressure <140 mmHgTarget systolic blood pressure <140 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Undergoing regular PD for treatment of ESKD.
- On PD for ≥ 4 months. (We do not plan to enroll patients within the first 3 months of PD initiation because there can be large fluctuations in volume status and BP readings before patient coming into more of a steady state. We then require participants to have at least 1 month of BP data to allow calculation of an average pre-enrollment BP for screening for study entry.)
- Diagnosis of HTN defined as being on antihypertensive medications or having routine clinic SBP ≥ 140 mmHg averaged over prior one month to screening.
- Able to measure brachial BP.
Key exclusion criteria (6 listed)
- Planned transplant or HD transition < 4.5 months (the duration of study).
- Estimated life expectancy < 4.5 months (also determined by asking the treating nephrologist).
- Participation in another clinical trial that may affect BP management.
- Pregnancy, anticipated pregnancy, or breastfeeding as this will limit the use of certain antihypertension medications in the study and pose additional risks to the patient and many pregnant patients are transitioned over to hemodialysis.
- Incarceration or institutionalized living which may prohibit measurement of home BP.
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 |
|---|---|---|
| Target systolic blood pressure <120 mmHg.The target SBP <120 mmHg will be operationalized as SBP 100-119 mmHg in the intervention arm. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain SBP <120 mmHg in the interventional arm. If SBP were <100 mmHg at one visit or <105 mmHg at two consecutive visits, BP medications will be reduced to keep SBP in the range of 100 to 119 mmHg, to avoid hypotensive episodes. | Other | Intervention |
| Target systolic blood pressure <140 mmHgThe target SBP <140 mmHg will be operationalized as SBP 130-139 mmHg. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain <140 mmHg in the control arm. If SBP were <130 mmHg at one visit or <135 mmHg at two consecutive visits, BP medications will be tapered/discontinued to keep SBP in the range of 130 to 139 mmHg. | Other | Control |
Primary outcome
Feasibility of enrolling participants
Time frame: 4.5 months
The primary feasibility endpoint is the screen-to-enrollment ratio, calculated as the number of participants randomized divided by the number of potentially eligible individuals screened during the recruitment period. Physician refusal and patient refusal rates will also be reported.
6 secondary outcomes
Retention of study participants
Time frame: 4.5 months
Physician adherence to protocol recommendations for achieving target SBP
Time frame: 4.5 months
Patient adherence to home BP measurements and recommended adjustments in dialysis prescription and medications
Time frame: 4.5 months
SBP achieved in each arm
Time frame: 4.5 months
Change in residual kidney function under two different SBP targets
Time frame: 4.5 months
Safety of targeting SBP <120 mmHg vs. <140 mmHg
Time frame: 4.5 months
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Chi-yuan Hsu, MD, MS principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target systolic blood pressure <120 mmHg. and Target systolic blood pressure <140 mmHg in people with End Stage Kidney Disease (ESKD) and Hypertension (HTN), run by University of California, San Francisco at 3 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 5 inclusion and 6 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 Kashvi Gupta, MD, MPH (734-546-4545, Kashvi.Gupta@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of enrolling participants (time frame: 4.5 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 6 Nov 2026.