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Clinical study on the effects of combined hemodialysis and hemoperfusion on depressive status in maintenance hemodialysis patients.

A single-center, open-label, randomized, controlled study on the effects of combined hemodialysis and hemoperfusion on depressive status in maintenance hemodialysis patients.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114569
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease stage 5, hemodialysis

Interventions

Experimental group:Hemodialysis + hemoperfusion (pHA130 perfusion device)
Control group:hemodialysis

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years, gender not limited; (2) Stable maintenance hemodialysis for >=3 months, with a relatively fixed dialysis pattern; (3) Hemodialysis treatment 3 times a week, with a total treatment time of >=10 hours per week, vascular access not limited; (4) SDS score >=53; (5) Kt/v >= 1.2 in the 12 weeks prior to selection; (6) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with known allergies, contraindications, or intolerance to the materials used in the dialyzer or perfusion apparatus; (2) Patients whose laboratory indicators meet one or more of the following criteria: white blood cell count < 4 × 10?/L, platelet count < 60 × 10?/L, serum albumin < 30 g/L; (3) Patients with a blood flow rate < 200 ml/min; (4) Patients who have received regular hemoperfusion therapy for more than 3 consecutive months and at least once a week; (5) Patients with grade 4 chronic congestive heart failure according to the New York Heart Association classification; (6) Individuals with acute infections, severe heart, lung, liver, or nervous system diseases, or malignant tumors; (7) Pregnant or breastfeeding individuals; (8) Individuals who have participated in or are currently participating in clinical trials within the past 3 months; (9) Individuals with an expected survival of less than 1 year; (10) Individuals deemed unsuitable for this trial by the researchers.

Design outcomes

Primary

MeasureTime frame
depression score;

Secondary

MeasureTime frame
serum ß2-MG;PTH;CRP;IL-6;TNF;Indoxyl sulfate;p-Cresyl sulfate;life quality;sleeping quality;itching;

Countries

China

Contacts

Public ContactQing Yu, Minchao Cai

Shanghai General Hospital

cmc220@163.com+86 189 6454 6106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026