Fluid AccumulationDRIVE-UFNCT07637110
Dry Weight Reduction Intervention Via Extra Ultrafiltration
A study testing Ultrafiltration in people with Fluid Accumulation and Blood Pressure Management, run by University of Washington at 1 site in United States.
Trial summary
Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Accumulation, Blood Pressure Management, End Stage Renal Disease (ESRD)
- What is being tested?
- Ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Nov 2030
- 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
- Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:
- Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.
- OR
- Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score <75.
Who cannot join
- Age <18 years
- Receiving hemodialysis treatments for acute kidney injury
- Receiving hemodialysis treatments for less than four weeks
- Planned switch to peritoneal or home dialysis within next three months
- Current or planned incremental hemodialysis (less than 3 treatments per week)
- Current or planned intensive hemodialysis (four or more treatments per week)
Show all 19Show fewer
- Scheduled kidney transplantation
- Major cardiovascular or bleeding event within previous 90 days
- Receiving chemotherapy or radiation treatment for cancer
- History of cirrhosis with ascites
- Inability to complete 24-hour ambulatory blood pressure measurement
- Wheelchair dependance or other inability to complete six-minute walk test
- Pre-dialysis systolic blood pressure <100 mmHg
- Scheduled use of midodrine with hemodialysis treatments
- History of non-adherence with dialysis treatments
- Pregnancy
- Institutionalized
- Current or pending enrollment in hospice care
- Inappropriate for enrollment based on investigator or nephrologist discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwest Kidney Centers
Seattle, Washington, 98112
Luisa Rios-Avila, 2062589325, lrios1@uw.edu
About this study
Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations.
This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.
Read the detailed description
This is a randomized trial of patients who are receiving in-center hemodialysis treatments for end stage kidney disease and have clinical suspicion of fluid overload. Enrolled participants will be randomly assigned in 1:1:1 fashion to either a four-week ultrafiltration strategy, an eight-week ultrafiltration strategy, or continuation of their regular thrice weekly hemodialysis treatments. Each ultrafiltration strategy will add two extra four-hour ultrafiltration treatments per week plus pharmacist-guided tapering of blood pressure medications. We will test the impact of these strategies on primary outcomes of
- Change in 24-hour continuous ambulatory blood pressure from baseline to 24-weeks
- Change in symptoms of congestion from baseline to 24-weeks We will also test the impact of the treatment strategies on related symptoms, physical activity levels, hemodynamics. and measures of safety.
- Being tested
- Ultrafiltration
- Keywords
- ESRD, Volume overload, Fluid accumulation, End stage renal disease, Congestion, Chronic dialysis, Blood Pressure (High), Blood pressure management
- Medical subject headings
- Kidney Failure, Chronic, Edema, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrafiltrationProcedure or surgery
Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
| Study group | Role | What they receive |
|---|---|---|
| Ultrafiltration sessions for 4 weeks | Active comparator | Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments. Receives: Procedure: Ultrafiltration |
| Ultrafiltration sessions for 8 weeks | Active comparator | Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments. Receives: Procedure: Ultrafiltration |
| Control arm, no ultrafiltration sessions | No intervention | Participant receives only their regularly scheduled thrice weekly hemodialysis treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour continuous ambulatory blood pressure
Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.
Measured: Measurement performed at baseline compared to measurement performed at 24 weeks.
Symptoms of congestion.
Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.
Measured: Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid AccumulationStudies 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
- Parallel groups
- Model description
- This is a randomized trial to test the effects of two concentrated ultrafiltration strategies in patients receiving maintenance hemodialysis treatments. We will determine the impact of the ultrafiltration strategies on blood pressure, congestion symptoms, and other key metrics of efficacy and safety
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Kestenbaum, University of Washington
- Investigators
- Bryan Kestenbaum, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637110
- Sponsor's protocol ID
- STUDY00025083
- Other IDs
- R01DK141693
- Acronym
- DRIVE-UF
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data and samples will be stored indefinitely for possible future uses. There will be no direct or indirect identifiers stored with the resources after this study is finished. Resources will be coded with study codes. We plan post de-identified data in public databases such as Dryad at study conclusion. NIH data sharing policies typically require us to post coded, deidentified individual-level data on one of the preferred platforms. We will work with our NIH project officer to post data after the study is finished to an appropriate platform. We may collaborate with colleagues and other researchers who demonstrate a legitimate research need for which data and samples from this study would be valuable. Future uses do not have any restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Weight Reduction Intervention Via Extra Ultrafiltration
- ClinicalTrials.gov ID
- NCT07637110
- Acronym / sponsor ID
- DRIVE-UF / STUDY00025083
- Keywords
- ESRD, Volume overload, Fluid accumulation, End stage renal disease, Congestion, Chronic dialysis, Blood Pressure (High), Blood pressure management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 9 Jun 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.
Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations.
This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.
Detailed description
This is a randomized trial of patients who are receiving in-center hemodialysis treatments for end stage kidney disease and have clinical suspicion of fluid overload. Enrolled participants will be randomly assigned in 1:1:1 fashion to either a four-week ultrafiltration strategy, an eight-week ultrafiltration strategy, or continuation of their regular thrice weekly hemodialysis treatments. Each ultrafiltration strategy will add two extra four-hour ultrafiltration treatments per week plus pharmacist-guided tapering of blood pressure medications. We will test the impact of these strategies on primary outcomes of
- Change in 24-hour continuous ambulatory blood pressure from baseline to 24-weeks
- Change in symptoms of congestion from baseline to 24-weeks We will also test the impact of the treatment strategies on related symptoms, physical activity levels, hemodynamics. and measures of safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized trial to test the effects of two concentrated ultrafiltration strategies in patients receiving maintenance hemodialysis treatments. We will determine the impact of the ultrafiltration strategies on blood pressure, congestion symptoms, and other key metrics of efficacy and safety
| Arm | Type | Receives |
|---|---|---|
| Ultrafiltration sessions for 4 weeks | Active comparator | Procedure: UltrafiltrationTwo ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments. |
| Ultrafiltration sessions for 8 weeks | Active comparator | Procedure: UltrafiltrationTwo ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments. |
| Control arm, no ultrafiltration sessions | No intervention | –Participant receives only their regularly scheduled thrice weekly hemodialysis treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:
- OR
Key exclusion criteria (19 listed)
- Age <18 years
- Receiving hemodialysis treatments for acute kidney injury
- Receiving hemodialysis treatments for less than four weeks
- Planned switch to peritoneal or home dialysis within next three months
- Current or planned incremental hemodialysis (less than 3 treatments per week)
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 |
|---|---|---|
| UltrafiltrationUltrafiltration for 4 or 8 weeks compared to no ultrafiltration. | Procedure or surgery | Ultrafiltration sessions for 4 weeks, Ultrafiltration sessions for 8 weeks |
Primary outcome
24-hour continuous ambulatory blood pressure
Time frame: Measurement performed at baseline compared to measurement performed at 24 weeks.
Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.
Symptoms of congestion.
Time frame: Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes. All data and samples will be stored indefinitely for possible future uses. There will be no direct or indirect identifiers stored with the resources after this study is finished. Resources will be coded with study codes. We plan post de-identified data in public databases such as Dryad at study conclusion. NIH data sharing policies typically require us to post coded, deidentified individual-level data on one of the preferred platforms. We will work with our NIH project officer to post data after the study is finished to an appropriate platform. We may collaborate with colleagues and other researchers who demonstrate a legitimate research need for which data and samples from this study would be valuable. Future uses do not have any restrictions.
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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.
Bryan Kestenbaum, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrafiltration in people with Fluid Accumulation and Blood Pressure Management, run by University of Washington at 1 site 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 4 inclusion and 19 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 9 Jun 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 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 Luisa Rios-Avila (206-258-9325, lrios1@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour continuous ambulatory blood pressure (time frame: Measurement performed at baseline compared to measurement performed at 24 weeks.). The study lists 2 primary outcomes in all. 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 9 Jun 2026.