Hemodiafiltration With Endogenous Reinfusion on Uremic Toxins Clearance of Maintenance Hemodialysis Patients

NCT ID: NCT06002529

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2025-07-01

Brief Summary

1.1Primary Objective To evaluate the clearance rate of uremic toxin β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC) by HFR.

1.2Secondary Objectives 1.1.1 To evaluate the clearance of low molecular weight uremic toxin urea (spKt/V, URR).

1.1.2 To evaluate the clearance of other middle molecules and macromolecular uremic toxins, including α1-microglobulin (α1-MG), κ-free light chain (κFLC), homocysteine (Hcy), interleukin-6 (IL-6), p-cresol, YKL-40, complement factor D (CFD), leptin, hippuric acid, trimethylamine oxide (TMAO), asymmetric dimethylarginine (ADMA), tumor necrosis factor-α (TNF- α), myoglobin, fibroblast growth factor 23 (FGF23) and intact parathyroid hormone (iPTH).

1.1.3 To evaluate the clearance of serum albumin, branched chain amino acids and vitamins A, C, E.

1.1.4 To evaluate the comfort of HFR treatment for MHD patients.

Conditions

To Evaluate the Clearance Rate of Uremic Toxin by HFR

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HFR treatment

patient received HFR treatment

Group Type: OTHER

HFR

Intervention Type: OTHER

patient received HFR treatment

Interventions

HFR

patient received HFR treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-75 years old, regardless of gender.
• MHD for at least 3 months, and blood purification treatment for 3 times per week.
• The vascular access is autogenous arteriovenous fistula or artificial blood vessels，with a blood flow ≥200mL/min.
• spKt/V≥1.2.
• Patients who signed the informed consent form (ICF) voluntarily.

Exclusion Criteria

• Patients who have participated in other interventional clinical trials within a month.
• Pregnant or lactating women.
• Patients of NYHA class IV or occurred acute coronary syndrome or myocardial infarction in 3 months before the start of the study.
• Patients with active hemorrhage in 2 weeks (e.g., cerebral hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage, etc.).
• Patients with unstable blood pressure (pre-dialysis systolic blood pressure ≥180 or ≤90mmHg, pre-dialysis diastolic blood pressure ≥100 or ≤60mmHg), severe anemia (hemoglobin ≤60g/L), and high risk of blood coagulation (e.g., albumin ≤25g/L or hemoglobin ≥140g/L).
• Patients with severe infection (the level of hypersensitive C-reactive protein(hsCRP) ≥ 10×upper limit of normal).
• Patients with a history of drug addiction or severe mental disorders.
• Other conditions in which the investigators reject patients to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Renhua Lu

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Renhua Lu

Role: CONTACT

lurenhua1977@hotmail.com

+8613361958582

Other Identifiers

KY2023-077

Identifier Type: -

Identifier Source: org_study_id