End Stage Renal Disease on DialysisNCT07016841
Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins
An observational study of End Stage Renal Disease on Dialysis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- pHA130 hemoperfusion device, HD/HDF and HA130 hemoperfusion device
- Type of treatment
- Medical device
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Stable maintenance hemodialysis patients meeting the inclusion and exclusion criteria with a dialysis vintage ≥3 months.
Who may be able to join
- Age ≥18 years, with no restriction on gender;
- Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;
- Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.
Who cannot join
- Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;
- Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;
- Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;
- Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;
- Patients with a platelet count < 60 × 10⁹/L;
- Other conditions deemed unsuitable for enrollment in this study by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study
This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Adults on thrice-weekly, 4-hour HD for at least three months are randomized to one of three arms: HD/HDF alone; HD/HDF plus biweekly pHA130 hemoperfusion; or HD/HDF plus biweekly HA130 hemoperfusion. After a four-week washout, toxin levels are measured at baseline and again at Weeks 4, 12, and 24, with the primary endpoint being the reduction in IS and PCS at Week 24. Secondary endpoints include single-session toxin removal, middle-molecule clearance (β₂-microglobulin, PTH), patient-reported outcomes (itching, sleep, quality of life), and rates of hospitalization and mortality. Safety is closely monitored through adverse event reporting and consistent anticoagulation dosing. Findings will clarify the clinical value of pHA130 hemoperfusion for improving toxin clearance and guiding optimal dialysis strategies.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- pHA130 hemoperfusion device, HD/HDF, HA130 hemoperfusion device
- Keywords
- Hemoadsorption, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHA130 hemoperfusion deviceDevice
HP once every 2 weeks.
HD/HDFDevice
HD twice weekly, HDF once weekly, with each session lasting 4 hours.
HA130 hemoperfusion deviceDevice
HP once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Treatment regimen: Hemodialysis (HD)/Hemodiafiltration (HDF) combined with Hemoperfusion (HP) using the pHA130 hemoperfusion device, with HD administered twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks. Receives: Device: pHA130 hemoperfusion device; Device: HD/HDF | |
| control group 1 | Control Group 1: HD/HDF Treatment regimen: HD twice weekly, HDF once weekly, with each session lasting 4 hours. Receives: Device: HD/HDF | |
| control group 2 | Control Group 2: HD/HDF combined with HP (HA130 hemoperfusion device) Treatment regimen: HD twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks. Receives: Device: HD/HDF; Device: HA130 hemoperfusion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum indoxyl sulfate (IS)
value at 24 weeks minus value at baseline reported
Measured: Week 0 to Week 24 (±7 days)
Serum p-cresyl sulfate (PCS)
value at 24 weeks minus value at baseline reported
Measured: Week 0 to Week 24 (±7 days)
Secondary outcomes (9)
Parathyroid hormone (PTH)
Reduction rate of parathyroid hormone (PTH) before/after a single treatment session
Measured: before/after a single treatment session
β2-microglobulin (β2-MG)
Reduction rate of β2-microglobulin (β2-MG) before/after a single treatment session.
Measured: before/after a single treatment session
Serum indoxyl sulfate (IS)
Reduction rate of serum indoxyl sulfate (IS) before/after a single treatment session
Measured: before/after a single treatment session
Serum p-cresyl sulfate (PCS)
Reduction rate of serum p-cresyl sulfate (PCS) before/after a single treatment session.
Measured: before/after a single treatment session
Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score
Change in KDQOL-SF (Kidney Disease Quality of Life Short Form) total score from baseline to week 24.
Measured: Week 0 to Week 24 (±7 days)
Pruritus severity score
Change from baseline in pruritus severity score (VAS and Modified Duo Pruritus Score) at Week 24.
Measured: Week 0 to Week 24 (±7 days)
Pittsburgh Sleep Quality Index (PSQI)
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 24
Measured: Week 0 to Week 24 (±7 days)
Hospitalization rate
24-week hospitalization rate (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom hospitalization rate)
Measured: Week 0 to Week 24 (±7 days)
Mortality rate
24-week-mortality (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom )
Measured: Week 0 to Week 24 (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start12 May 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016841
- Sponsor's protocol ID
- XH-25-005
- Status last verified
- Jul 2026
- First submitted
- 26 May 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07016841
- Acronym / sponsor ID
- XH-25-005
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Hemoadsorption, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 12 Jun 2025 (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.
This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Adults on thrice-weekly, 4-hour HD for at least three months are randomized to one of three arms: HD/HDF alone; HD/HDF plus biweekly pHA130 hemoperfusion; or HD/HDF plus biweekly HA130 hemoperfusion. After a four-week washout, toxin levels are measured at baseline and again at Weeks 4, 12, and 24, with the primary endpoint being the reduction in IS and PCS at Week 24. Secondary endpoints include single-session toxin removal, middle-molecule clearance (β₂-microglobulin, PTH), patient-reported outcomes (itching, sleep, quality of life), and rates of hospitalization and mortality. Safety is closely monitored through adverse event reporting and consistent anticoagulation dosing. Findings will clarify the clinical value of pHA130 hemoperfusion for improving toxin clearance and guiding optimal dialysis strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Device: pHA130 hemoperfusion device, Device: HD/HDFTreatment regimen: Hemodialysis (HD)/Hemodiafiltration (HDF) combined with Hemoperfusion (HP) using the pHA130 hemoperfusion device, with HD administered twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks. |
| control group 1 | – | Device: HD/HDFControl Group 1: HD/HDF Treatment regimen: HD twice weekly, HDF once weekly, with each session lasting 4 hours. |
| control group 2 | – | Device: HD/HDF, Device: HA130 hemoperfusion deviceControl Group 2: HD/HDF combined with HP (HA130 hemoperfusion device) Treatment regimen: HD twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable maintenance hemodialysis patients meeting the inclusion and exclusion criteria with a dialysis vintage ≥3 months.
Key inclusion criteria (3 listed)
- Age ≥18 years, with no restriction on gender;
- Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;
- Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.
Key exclusion criteria (6 listed)
- Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;
- Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;
- Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;
- Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;
- Patients with a platelet count < 60 × 10⁹/L;
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 hemoperfusion deviceHP once every 2 weeks. | Device | experimental group |
| HD/HDFHD twice weekly, HDF once weekly, with each session lasting 4 hours. | Device | control group 1, control group 2, experimental group |
| HA130 hemoperfusion deviceHP once every 2 weeks. | Device | control group 2 |
Primary outcome
Serum indoxyl sulfate (IS)
Time frame: Week 0 to Week 24 (±7 days)
value at 24 weeks minus value at baseline reported
Serum p-cresyl sulfate (PCS)
Time frame: Week 0 to Week 24 (±7 days)
value at 24 weeks minus value at baseline reported
9 secondary outcomes
Parathyroid hormone (PTH)
Time frame: before/after a single treatment session
β2-microglobulin (β2-MG)
Time frame: before/after a single treatment session
Serum indoxyl sulfate (IS)
Time frame: before/after a single treatment session
Serum p-cresyl sulfate (PCS)
Time frame: before/after a single treatment session
Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score
Time frame: Week 0 to Week 24 (±7 days)
Pruritus severity score
Time frame: Week 0 to Week 24 (±7 days)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 0 to Week 24 (±7 days)
Hospitalization rate
Time frame: Week 0 to Week 24 (±7 days)
Mortality rate
Time frame: Week 0 to Week 24 (±7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease on Dialysis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 3 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: finished, as of the sponsor's last update on 10 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum indoxyl sulfate (IS) (time frame: Week 0 to Week 24 (±7 days)). 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 10 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.