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A prospective, multicenter, randomized, open-label, parallel-positive controlled non-inferiority clinical trial evaluating the safety and efficacy of hollow fibrous hemodialysis filters for hemodialysis therapy in patients with chronic renal failure

A prospective, multicenter, randomized, open-label, parallel-positive controlled non-inferiority clinical trial evaluating the safety and efficacy of hollow fibrous hemodialysis filters for hemodialysis therapy in patients with chronic renal failure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075002
Enrollment
Unknown
Registered
2023-08-22
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Acute and chronic renal failure

Interventions

experimental group:HDF180 hollow fiber hemodialysis filter
control group:FX800HDF hollow fiber hemodialysis/filter

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with maintenance hemodialysis of chronic renal failure who have received hemodialysis treatment for more than 3 months; (2) 18 years old= age = 80 years old, gender is not limited; (3) Patients with regular hemodialysis, dialysis 2-3 times a week; (4) It can ensure that the blood flow during hemodialysis is not less than 200mL/min; (5) Patients with autologous arteriovenous fistula with vascular access; The subject or his/her guardian was able to understand the purpose of the study, voluntarily participate and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who received any kind of blood purification treatment, including hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), hemoperfusion (HP), continuous renal replacement therapy (CRRT), etc., within 24 hours before the test was put on the machine, and had an impact on the evaluation of the trial; (2) Patients with severe anemia (hemoglobin content < 60g/L); (3) Patients with severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3 times the upper limit of normal); (4) Have severe neurological diseases, myocardial infarction, severe myocardial lesions and refractory heart failure or NYHA grade 4 within 1 month before enrollment; (5) Severe hypertension (controlled systolic blood pressure = 180mmHg or diastolic blood pressure =110mmHg) before diastolen); (6) Combined with intracranial hemorrhage or increased intracranial pressure, severe shock that is difficult to correct with drugs, systemic infection or uncontrolled local infection, history of AIDS or syphilis, active malignant tumor, active tuberculosis or failure of other important organs other than kidneys; (7) Patients with hemodialysis combined with peritoneal dialysis; (8) Patients with psychiatric diseases or medical history; (9) Patients with low weight (< 40kg); (10) Those who have participated in other clinical trials within 1 month; (11) Those with a history of polysulfone allergy, and those with a history of previous allergy to extracorporeal circulation pipelines and filters; (12) pregnant and lactating women; (13) Those who the investigator believes are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
ß 2-microglobulin;creatinine;Urea nitrogen;

Secondary

MeasureTime frame
Blood electrolyte;liver function;CRP;Blood gas;

Countries

China

Contacts

Public ContactNian song Wang

Shanghai Sixth People's Hospital

wangniansong2012@163.com+86 189 3017 7399

Outcome results

None listed

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