Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure (PHOENIX)

14 juni 2026 bijgewerkt door: Wenge Li, MD, PhD, China-Japan Friendship Hospital

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Shimin Jiang, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HAHD Group
Participants assigned to this group will receive a combination of hemodialysis (HD) and hemoadsorption (HA) therapy.
Apparaat: pHA130 Hemoadsorption Cartridge
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.
Actieve vergelijker: HD Group
Participants assigned to this group will receive standard maintenance hemodialysis therapy.
Apparaat: High-flux Hemodialyzer
Patients receive conventional high-flux hemodialysis (HD) three times a week. Each treatment session lasts for 4 hours.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration
Tijdsspanne: 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).
Baseline, 3, 6, 9, 12 Months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in Health-Related Quality of Life (HRQoL)
Tijdsspanne: Baseline, 3, 6, 9, 12 Months
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.
Baseline, 3, 6, 9, 12 Months
Change from baseline in Cognitive Function
Tijdsspanne: Baseline, 3, 6, 9, 12 Months
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).
Baseline, 3, 6, 9, 12 Months
Progression of Coronary Artery Calcification (CAC)
Tijdsspanne: Baseline, 6, 12 Months
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.
Baseline, 6, 12 Months
All-Cause Mortality
Tijdsspanne: Up to 12 Months
Number of deaths from any cause during the study period.
Up to 12 Months
Incidence of Major Adverse Cardiovascular Events (MACEs)
Tijdsspanne: Up to 12 Months
MACEs are defined as a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death.
Up to 12 Months
Incidence of Adverse Events
Tijdsspanne: Baseline, 3, 6, 9, 12 Months
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.
Baseline, 3, 6, 9, 12 Months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

China-Japan Friendship Hospital

Medewerkers

Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

Onderzoekers

  • Hoofdonderzoeker: Wenge Li, MD, China-Japan Friendship Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 april 2028

Studie voltooiing (Geschat)

1 augustus 2028

Studieregistratiedata

Eerst ingediend

9 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-KY-177-1

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op ESRD (End-Stage Renal Disease)

Klinische onderzoeken op pHA130 Hemoadsorption Cartridge

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Myanmar

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren