ESRD (End-Stage Renal Disease)PHOENIXNCT07656168
Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure
A study testing pHA130 Hemoadsorption Cartridge and High-flux Hemodialyzer in people with ESRD (End-Stage Renal Disease) and Maintenance Hemodialysis, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD (End-Stage Renal Disease), Maintenance Hemodialysis
- What is being tested?
- pHA130 Hemoadsorption Cartridge and High-flux Hemodialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to Aug 2028
- 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.
- On maintenance hemodialysis for > 3 months.
- Receiving hemodialysis 3 times per week, 4 hours per session.
- Standard Kt/V ≥ 1.2.
- Voluntarily participates and provides written informed consent.
Who cannot join
- Known allergy to the dialyzer or hemoperfusion device.
- Platelet count < 60×10⁹/L.
- Serum albumin < 30 g/L.
- 24-hour urine output > 200 ml.
- Inability to achieve a blood flow rate ≥ 200 ml/min.
- Coagulation disorders, severe bleeding tendency, or active bleeding.
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- Pre-dialysis systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg.
- Active malignancy.
- Active infection, or severe, critical illness of cardiac, pulmonary, hepatic, or nervous systems.
- Planned living-donor kidney transplant within the next 6 months.
- Current participation in another interventional clinical study, or participation within the past 3 months in an interventional study that may interfere with the present study (e.g., fecal microbiota transplantation); or use of intestinal microecological regulators such as probiotics.
- History of unstable angina, myocardial infarction, malignant arrhythmia, cardiac or peripheral vascular surgery, or cerebrovascular accident within the past 8 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shimin Jiang, PhD contact
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Jian Lu
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial of HAHD With pHA130 Cartridge vs. Conventional High-Flux HD for Clearance of Protein-Bound Uremic Toxins and Quality of Life Improvement in Kidney Failure.
Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). The accumulation of these toxins is associated with adverse long-term outcomes.
This study evaluates the efficacy and safety of the pHA130 hemoadsorption cartridge, which utilizes a modified resin for enhanced PBUT adsorption, when combined with hemodialysis (HAHD). This is a prospective, open-label, multi-center, randomized controlled trial involving 100 MHD patients. Participants will be randomized 1:1 to either the HAHD group (receiving one HAHD session using the pHA130 cartridge and two standard HD sessions weekly) or the Control group (receiving three standard HD sessions weekly).
The primary objective is to assess the reduction in serum indoxyl sulfate (IS) and p-cresol sulfate (PCS) levels from baseline to 12 months. Secondary objectives include evaluating changes in quality of life (KDQoL-SF, MMSE), the progression of coronary artery calcification (CAC), the incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety profiles. This trial aims to determine if integrating long-term HAHD therapy can optimize blood purification strategies for the MHD population.
Read the detailed description
Patients with chronic kidney disease (CKD), particularly those on maintenance hemodialysis (MHD), face a high burden of cardiovascular disease and significantly impaired health-related quality of life. Traditional hemodialysis (HD) and hemodiafiltration (HDF) are effective at clearing small water-soluble molecules, but their efficacy in removing protein-bound uremic toxins (PBUTs)-such as indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-is notably limited. The accumulation of PBUTs is strongly associated with vascular calcification, increased cardiovascular mortality, and severe symptoms like uremic pruritus.
Hemoadsorption combined with hemodialysis (HAHD) has emerged as a promising strategy to address this gap. The novel pHA130 hemoadsorption cartridge features a modified resin with micro-controlled positive charges, enhancing its targeted adsorption capacity for PBUTs through electrostatic, hydrophobic, and molecular sieving mechanisms. In vitro studies have shown IS and PCS clearance rates exceeding 90%.
The PHOENIX trial is a prospective, open-label, multicenter, randomized controlled trial designed to evaluate the long-term clinical efficacy and safety of the pHA130 cartridge in MHD patients. Following a 4-week run-in period, eligible participants will be randomized 1:1 into two arms:
Experimental Group (HAHD): Receives high-flux HD twice a week and HAHD once a week. During HAHD, the pHA130 cartridge is placed in series before the high-flux dialyzer.
Control Group (HD): Receives conventional high-flux HD three times a week.
The primary endpoint is the percentage reduction in serum IS and PCS concentrations from baseline to 12 months. Secondary endpoints include changes in health-related quality of life (assessed by KDQoL-SF) and cognitive function (assessed by MMSE), progression of coronary artery calcification (CAC) measured by Agatston score, incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety metrics. The results of this study aim to provide robust evidence for optimizing blood purification strategies and improving long-term outcomes for patients with end-stage renal disease.
- Being tested
- pHA130 Hemoadsorption Cartridge, High-flux Hemodialyzer
- Keywords
- Hemoadsorption, Protein-Bound Uremic Toxins, Indoxyl Sulfate, p-Cresyl Sulfate, Cardiovascular Events, Quality of Life
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHA130 Hemoadsorption CartridgeDevice
Following a 4-week run-in period,patients receive High-flux hemodialysis (HD) twice a week and combined HAHD once a week. During the HAHD session, the pHA130 hemoadsorption cartridge is placed in series with a high-flux dialyzer. Each treatment session lasts for 4 hours.
High-flux HemodialyzerDevice
Patients receive conventional high-flux hemodialysis (HD) three times a week. Each treatment session lasts for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| HAHD Group | Experimental | Participants assigned to this group will receive a combination of hemodialysis (HD) and hemoadsorption (HA) therapy. Receives: Device: pHA130 Hemoadsorption Cartridge |
| HD Group | Active comparator | Participants assigned to this group will receive standard maintenance hemodialysis therapy. Receives: Device: High-flux Hemodialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration
Percentage reduction in serum IS and PCS concentration from baseline after 12 months of treatment, measured by High-Performance Liquid Chromatography (HPLC).
Measured: Baseline, 3, 6, 9, 12 Months
Secondary outcomes (6)
Change from baseline in Health-Related Quality of Life (HRQoL)
Health-Related Quality of Life (HRQoL) is assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF). The KDQOL-SF scores range from a minimum of 0 to a maximum of 100. A higher score indicates a better health-related quality of life.
Measured: Baseline, 3, 6, 9, 12 Months
Change from baseline in Cognitive Function
Cognitive function is assessed using the Mini-Mental State Examination (MMSE). The MMSE total score ranges from a minimum of 0 to a maximum of 30. A lower score indicates more severe cognitive impairment (i.e., a higher score reflects better cognitive function).
Measured: Baseline, 3, 6, 9, 12 Months
Progression of Coronary Artery Calcification (CAC)
Coronary Artery Calcification (CAC) progression is assessed by measuring the change in the Agatston score using Computed Tomography (CT) scans. The Agatston score has a minimum value of 0, with no defined maximum upper limit. A higher score indicates a greater burden of coronary artery calcification and a higher cardiovascular risk.
Measured: Baseline, 6, 12 Months
All-Cause Mortality
Number of deaths from any cause during the study period.
Measured: Up to 12 Months
Incidence of Major Adverse Cardiovascular Events (MACEs)
MACEs are defined as a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death.
Measured: Up to 12 Months
Incidence of Adverse Events
Safety will be evaluated by monitoring and recording the incidence, severity, and relationship to the intervention of any adverse events (AEs) or serious adverse events (SAEs) throughout the study period.
Measured: Baseline, 3, 6, 9, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jun 2026
- Primary completionApr 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRD (End-Stage Renal Disease)Studies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Principal investigator, Wenge Li, MD, PhD, China-Japan Friendship Hospital
- Investigators
- Wenge Li, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656168
- Sponsor's protocol ID
- 2025-KY-177-1
- Acronym
- PHOENIX
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 25 Jun 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial of HAHD With pHA130 Cartridge vs. Conventional High-Flux HD for Clearance of Protein-Bound Uremic Toxins and Quality of Life Improvement in Kidney Failure.
- ClinicalTrials.gov ID
- NCT07656168
- Acronym / sponsor ID
- PHOENIX / 2025-KY-177-1
- Keywords
- Hemoadsorption, Protein-Bound Uremic Toxins, Indoxyl Sulfate, p-Cresyl Sulfate, Cardiovascular Events, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 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.
Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). The accumulation of these toxins is associated with adverse long-term outcomes.
This study evaluates the efficacy and safety of the pHA130 hemoadsorption cartridge, which utilizes a modified resin for enhanced PBUT adsorption, when combined with hemodialysis (HAHD). This is a prospective, open-label, multi-center, randomized controlled trial involving 100 MHD patients. Participants will be randomized 1:1 to either the HAHD group (receiving one HAHD session using the pHA130 cartridge and two standard HD sessions weekly) or the Control group (receiving three standard HD sessions weekly).
The primary objective is to assess the reduction in serum indoxyl sulfate (IS) and p-cresol sulfate (PCS) levels from baseline to 12 months. Secondary objectives include evaluating changes in quality of life (KDQoL-SF, MMSE), the progression of coronary artery calcification (CAC), the incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety profiles. This trial aims to determine if integrating long-term HAHD therapy can optimize blood purification strategies for the MHD population.
Detailed description
Patients with chronic kidney disease (CKD), particularly those on maintenance hemodialysis (MHD), face a high burden of cardiovascular disease and significantly impaired health-related quality of life. Traditional hemodialysis (HD) and hemodiafiltration (HDF) are effective at clearing small water-soluble molecules, but their efficacy in removing protein-bound uremic toxins (PBUTs)-such as indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-is notably limited. The accumulation of PBUTs is strongly associated with vascular calcification, increased cardiovascular mortality, and severe symptoms like uremic pruritus.
Hemoadsorption combined with hemodialysis (HAHD) has emerged as a promising strategy to address this gap. The novel pHA130 hemoadsorption cartridge features a modified resin with micro-controlled positive charges, enhancing its targeted adsorption capacity for PBUTs through electrostatic, hydrophobic, and molecular sieving mechanisms. In vitro studies have shown IS and PCS clearance rates exceeding 90%.
The PHOENIX trial is a prospective, open-label, multicenter, randomized controlled trial designed to evaluate the long-term clinical efficacy and safety of the pHA130 cartridge in MHD patients. Following a 4-week run-in period, eligible participants will be randomized 1:1 into two arms:
Experimental Group (HAHD): Receives high-flux HD twice a week and HAHD once a week. During HAHD, the pHA130 cartridge is placed in series before the high-flux dialyzer.
Control Group (HD): Receives conventional high-flux HD three times a week.
The primary endpoint is the percentage reduction in serum IS and PCS concentrations from baseline to 12 months. Secondary endpoints include changes in health-related quality of life (assessed by KDQoL-SF) and cognitive function (assessed by MMSE), progression of coronary artery calcification (CAC) measured by Agatston score, incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety metrics. The results of this study aim to provide robust evidence for optimizing blood purification strategies and improving long-term outcomes for patients with end-stage renal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAHD Group | Experimental | Device: pHA130 Hemoadsorption CartridgeParticipants assigned to this group will receive a combination of hemodialysis (HD) and hemoadsorption (HA) therapy. |
| HD Group | Active comparator | Device: High-flux HemodialyzerParticipants assigned to this group will receive standard maintenance hemodialysis therapy. |
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.
- On maintenance hemodialysis for > 3 months.
- Receiving hemodialysis 3 times per week, 4 hours per session.
- Standard Kt/V ≥ 1.2.
- Voluntarily participates and provides written informed consent.
Key exclusion criteria (12 listed)
- Known allergy to the dialyzer or hemoperfusion device.
- Platelet count < 60×10⁹/L.
- Serum albumin < 30 g/L.
- 24-hour urine output > 200 ml.
- Inability to achieve a blood flow rate ≥ 200 ml/min.
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 |
|---|---|---|
| pHA130 Hemoadsorption CartridgeFollowing a 4-week run-in period,patients receive High-flux hemodialysis (HD) twice a week and combined HAHD once a week. During the HAHD session, the pHA130 hemoadsorption cartridge is placed in series with a high-flux dialyzer. Each treatment session lasts for 4 hours. | Device | HAHD Group |
| High-flux HemodialyzerPatients receive conventional high-flux hemodialysis (HD) three times a week. Each treatment session lasts for 4 hours. | Device | HD Group |
Primary outcome
Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration
Time frame: Baseline, 3, 6, 9, 12 Months
Percentage reduction in serum IS and PCS concentration from baseline after 12 months of treatment, measured by High-Performance Liquid Chromatography (HPLC).
6 secondary outcomes
Change from baseline in Health-Related Quality of Life (HRQoL)
Time frame: Baseline, 3, 6, 9, 12 Months
Change from baseline in Cognitive Function
Time frame: Baseline, 3, 6, 9, 12 Months
Progression of Coronary Artery Calcification (CAC)
Time frame: Baseline, 6, 12 Months
All-Cause Mortality
Time frame: Up to 12 Months
Incidence of Major Adverse Cardiovascular Events (MACEs)
Time frame: Up to 12 Months
Incidence of Adverse Events
Time frame: Baseline, 3, 6, 9, 12 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 25 Jun 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.
Shimin Jiang, PhD contact
Wenge Li, MD principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pHA130 Hemoadsorption Cartridge and High-flux Hemodialyzer in people with ESRD (End-Stage Renal Disease) and Maintenance Hemodialysis, run by China-Japan Friendship Hospital at 1 site in China.
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 12 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 25 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 China. 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 Jian Lu, PhD (+8619834515101, lujiandr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration (time frame: Baseline, 3, 6, 9, 12 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 25 Jun 2026.