Hemodiafiltration With Endogenous Reinfusion on Uremic To... | NCT06002529

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

NCT06002529

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Aug 21, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

To Evaluate the Clearance Rate of Uremic Toxin by HFR

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2023Estimated

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Jul 1, 2025Estimated

First Submitted Date

Jul 10, 2023

First Submission Date that Met QC Criteria

Aug 15, 2023

First Posted Date

Aug 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2023

Last Update Posted Date

Aug 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
HFR treatment	Other	patient received HFR treatment	Other: HFR

Name	Type	Description	Arm Group Labels	Other Names
HFR	Other	patient received HFR treatment	HFR treatment

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Renhua Lu	Contact	+8613361958582		lurenhua1977@hotmail.com

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided