Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

NCT07111260 | Recruiting

• 1 other identifier: 2025PHB095-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, crossover study to evaluate the efficacy of extending the duration of hemoadsorption (HA) combined with hemodialysis (HD) from 2 hours to 4 hours for clearing protein-bound uremic toxins, such as Indoxyl Sulfate (IS), in stable maintenance hemodialysis patients. Patients will be randomized to receive either 2-hour HA or 4-hour HA once a week for 8 weeks, then cross over to the other treatment for another 8 weeks after a 2-week washout period. The primary endpoint is the reduction rate of IS.

Conditions

End Stage Renal Disease on Dialysis

Keywords

Hemoadsorption; Duration

Outcome Measures

Primary Outcomes (1)

• Reduction Rate of Serum Indoxyl Sulfate (IS)

  The reduction rate (RR) of serum Indoxyl Sulfate (IS) after a single HAHD treatment session. The RR is calculated as: RR(%) = (1 - (Post-treatment Concentration / Pre-treatment Concentration)) × 100. Post-treatment concentration will be corrected for hemoconcentration.

  At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit

Secondary Outcomes (5)

• Reduction Rate of p-Cresyl Sulfate (PCS)

  At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit

• Change from Baseline in Pre-dialysis IS levels

  Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18)

• Change from Baseline in Pre-dialysis PCS levels

  Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18)

• Clearance of Other Uremic Toxins

  Week 1, Week 8, Week 11, Week 18

• Number of Participants With Adverse Events, Circuit Coagulation, and Abnormal Changes in Vital Signs or Laboratory Parameters

  Throughout the entire study duration (up to 18 weeks)

Study Arms (2)

4-Hour HA Group

EXPERIMENTAL

Subjects receive high-flux hemodialysis (HFHD) twice a week and hemoadsorption combined with HFHD (HAHD) once a week. The HAHD session, using a pHA130 cartridge, lasts for the entire 4-hour duration of the dialysis session. Blood flow rate is maintained at 250-350 mL/min, consistent with the patient's original HD prescription.

Device: pHA130 Hemoadsorption + High-Flux Hemodialysis

2-Hour HA Group

ACTIVE COMPARATOR

Subjects receive high-flux hemodialysis (HFHD) twice a week and HAHD once a week. The hemoadsorption component, using a pHA130 cartridge, is performed for the first 2 hours of the session, after which the pHA130 cartridge is removed and the patient continues with standard HFHD for the remaining 2 hours. Blood flow rate during HA is 200-250 mL/min.

Device: pHA130 Hemoadsorption + High-Flux Hemodialysis

Interventions

pHA130 Hemoadsorption + High-Flux Hemodialysis DEVICE

A combination blood-purification procedure in which a pHA130 hemoperfusion cartridge is connected in series with a high-flux hemodialyzer. Blood first passes through the HP cartridge to adsorb protein-bound uremic toxins and is then dialyzed. In the 4-hour arm the HP cartridge remains online for the entire 4-hour session; in the 2-hour arm the cartridge is removed after 2 hours and dialysis continues alone for the remaining 2 hours. Blood-flow rates are 250-350 mL/min (4-hour arm) or 200-250 mL/min (2-hour arm).

2-Hour HA Group; 4-Hour HA Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years, regardless of gender
• Stable maintenance hemodialysis for ≥3 months, with a relatively fixed dialysis regimen
• Receiving hemodialysis 3 times per week, each session lasting ≥4 hours
• Single-pool Kt/V (spKt/V) ≥1.2 within 8 weeks prior to enrollment
• Willing and able to sign the informed consent form

You may not qualify if:

• Life expectancy less than 1 year
• White blood cell count \< 4 × 10⁹/L and/or platelet count \< 60 × 10⁹/L
• Active or chronic gastrointestinal bleeding, or diagnosed coagulation disorders
• Active malignant tumor
• Active infection
• Pregnant or breastfeeding
• Participation in another clinical trial within the past month or currently enrolled in one
• Deemed unsuitable for the study by the investigator

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Li Zuo

  Renal Division, Department of Medicine, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangying Gan

CONTACT

010-88324516; ganl@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)