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The comparison of the effects of Theranova dialyzer (medium cut-off dialyzer) and hemodialysis filtration on dialysis effect and peripheral blood cell gene expression in uremic hemodialysis patients

The comparison of the effects of Theranova dialyzer (medium cut-off dialyzer) and hemodialysis filtration on dialysis effect and peripheral blood cell gene expression in uremic hemodialysis patients

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081149
Enrollment
Unknown
Registered
2024-02-23
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Chronic kidney disease

Interventions

Theranova group:Use Theranova 400 for 1 week of mid week hemodialysis treatment
HDF group:Use HDF for one week of mid week hemodialysis treatment

Sponsors

the First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged >18 years old and 1.2 in the last 2 evaluations, and the last Kt/V evaluation was performed within 4 weeks before study screening or during study screening.

Exclusion criteria

Exclusion criteria: 1) Patients with acute kidney injury with potential for recovery; 2) Pregnant or lactating women; 3) Patients diagnosed with New York Heart Association (NYHA) Class IV congestive heart failure, or acute coronary syndrome and/or myocardial infarction within the past 3 months prior to study initiation; 4) Patients known to have hemodynamic instability, anemia (hemoglobin 130 g/L with coagulation risk; 5) Patients judged by the investigator to have active or persistent infection (e.g., patients with C-reactive protein [CRP] levels exceeding five times the upper limit of normal); 6) Patients with severe malnutrition or severe diseases affecting liver function (e.g., serum albumin <30 g/L); 7) Diagnosed with hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody (HCV-Ab) positive, with assessment by the investigator of advanced liver or pulmonary disease; 8) Patients diagnosed with human immunodeficiency virus (HIV) and positive for syphilis; 9) Patients receiving immunosuppressive therapy or with autoimmune diseases; 10) Patients with a history of solid tumors, receiving or anticipated to receive anticancer therapy in the past or next 6 months, or with an expected lifespan <1 year, or with a history of hematologic malignancy; 11) Patients with planned living kidney donation or considering switching to peritoneal dialysis (PD) or requesting single-needle dialysis within the next year; 12) Patients with allergies to polyarylethersulfone (PAES) or polysulfone (PS) membranes or poor tolerance to synthetic dialysis membranes; 13) Patients with a history of severe mental disorders unable to provide consent or comply with study procedures; 14) Currently participating in or having participated in other interventional clinical trials within the past 30 days.

Design outcomes

Primary

MeasureTime frame
XFLC RR;ß2-MG RR;C-reactive protein, CRP;Transcriptome sequencing data of peripheral blood total RNA;

Secondary

MeasureTime frame
Kt/V;URR;YKL-40 RR;

Countries

China

Contacts

Public ContactHuang Ying

the First Affiliated Hospital of Soochow University

yvonne1228@163.com+86 138 6212 1552

Outcome results

None listed

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