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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: To Evaluate the Clearance Rate of Uremic Toxin by HFR
• Intervention / Treatment: Other: HFR

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renhua Lu; Phone Number: +8613361958582; Email: lurenhua1977@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HFR treatment; patient received HFR treatment	Other: HFR; patient received HFR treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-compartment urea clearance index (spKt/V), Urea Reduction Ratio	Calculate spKt/V and Urea Reduction Ratio.	1 day
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	The concentrations of other middle molecules and macromolecular uremic were measured before and after HFR	1 day
serum albumin, branched chain amino acids and vitamins A, C, E	The concentrations of serum albumin, branched chain amino acids and vitamins A, C, E before and after HFR	1 day
the comfort of HFR treatment	The dialysis comfort score was used for evaluation	1 day

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 18, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KY2023-077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No