Clinical trial NCT06002529: Hemodiafiltration With Endogenous Reinfusion on Uremic Toxins Clearance of Maintenance Hemodialysis Patients
Official title: Hemodiafiltration With Endogenous Reinfusion on Uremic Toxins Clearance of Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: To Evaluate the Clearance Rate of Uremic Toxin by HFR
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC)
timeFrame: 1 day
Secondary outcomes:
measure: Single-compartment urea clearance index (spKt/V), Urea Reduction Ratio
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: serum albumin, branched chain amino acids and vitamins A, C, E
timeFrame: 1 day
measure: the comfort of HFR treatment
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: