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

Not Applicable

Not yet recruiting

• Conditions: To Evaluate the Clearance Rate of Uremic Toxin by HFR
• Interventions: Other: HFR

• Registration Number: NCT06002529
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-10
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study Start: 2023-08-18
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HFR treatment	HFR	patient received HFR treatment

Primary Outcome Measures

Name	Time	Method
β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC)	1 day	The concentrations of β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC) were measured before and after HFR

Secondary Outcome Measures

Name	Time	Method
serum albumin, branched chain amino acids and vitamins A, C, E	1 day	The concentrations of serum albumin, branched chain amino acids and vitamins A, C, E before and after HFR
Single-compartment urea clearance index (spKt/V), Urea Reduction Ratio	1 day	Calculate spKt/V and Urea Reduction Ratio.
other middle molecules and macromolecular uremic including α1-MG, κFLC, Hcy, IL-6, p-cresol, YKL-40, CFD, leptin, hippuric acid, TMAO, ADMA, TNF-α, myoglobin, FGF23 and iPTH	1 day	The concentrations of other middle molecules and macromolecular uremic were measured before and after HFR
the comfort of HFR treatment	1 day	The dialysis comfort score was used for evaluation