Recruiting

Ultrafiltration

Sponsor:

University of Washington

Code:

NCT07637110

Conditions

Fluid Accumulation

Blood Pressure Management

End Stage Renal Disease (ESRD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultrafiltration

Study Details

Brief 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.

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.

Conditions

Fluid Accumulation

Blood Pressure Management

End Stage Renal Disease (ESRD)

Study ID

NCT07637110

Start date

Sep 10, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. 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
2. Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score <75.

Exclusion Criteria:
  • 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)
  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ultrafiltration treatments for up to 4 weeks

Two ultrafiltration treatments per week for up to 4 weeks; pharmacist guided tapering of blood pressure medications for up to 4 weeks; and regular thrice weekly hemodialysis treatments.

active comparator: Ultrafiltration treatments for up to 8 weeks

Two ultrafiltration treatments per week for up to 8 weeks; pharmacist guided tapering of blood pressure medications for up to 8 weeks; and regular thrice weekly hemodialysis treatments.

no intervention: Control arm

Regular thrice weekly hemodialysis treatments.

Interventions

Ultrafiltration

Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.

Primary outcome measure

  • 24-hour continuous ambulatory blood pressure [ Time Frame: Measurement performed at baseline compared to measurement performed at 24 weeks. ]
  • Symptoms of congestion. [ Time Frame: Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks. ]

Central Contacts and Locations

Central contacts

Luisa Rios-Avila

206-258-9325lrios1@uw.edu

Ernest Ayers, MSPH

206-685-1423ayerse@uw.edu

Locations

Northwest Kidney Centers

Recruiting

Seattle, Washington, United States, 98112

Contacts

Luisa Rios-Avila

2062589325lrios1@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Keywords

  • ESRD
  • Volume overload
  • Fluid accumulation
  • End stage renal disease
  • Congestion
  • Chronic dialysis
  • Blood Pressure (High)
  • Blood pressure management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by University of Washington on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.