Clinical Trial for Effectiveness and Safety Evaluation of Hemodiafilter

NCT06454981 | Completed

• 1 other identifier: XH202101
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical trial was conducted in the nephrology department of Shulan (Hang Zhou) Hospital,the hemodialysis room of Wenzhou TCM Hospital, Jinhua Municipal Centeral Hospital, and Tongde Hospital of Zhejiang Province. The clinical trial is designed as a multi-center, randomized, open, positive parallel control, non-inferiority clinical trial. The control devices were positive devices approved by CFDA, which have been widely used and have been proven efficacy for the corresponding indications. The objective of the non-inferiority test is to show that the therapeutic effect of the experimental device is clinically non-inferior to that of the positive control device. The enrolled patients were randomly divided into the experimental group and the control group, using the "hemodiafilter" (experimental device) produced by Shinva Medical Instrument Co.,Ltd. and the FX 800HDF hollow fiber hemodialysis/filter (control device) produced by Fresenius Medical Care AG \& Co.KGaA (registered agent: Fresenius Medical Care (shanghai) Company Limted), respectively. To evaluate the effectiveness, safety and operability of the "hemodiafilter" produced by Shinva Medical Instrument Co.,Ltd. by means of control.Cases were screened according to the inclusion and exclusion criteria. The selected cases were randomised into groups in chronological order. Based on the principle of voluntary participation of subjects in clinical trial, before the commencement of the clinical trial, the purpose, process and duration of the clinical trial were explained in detail to the subjects, as well as the role of the subjects in using the experimental device on the clinic and the possible risks encountered and the measures to be taken, and the clinical trial was carried out after obtaining the consent of the subjects and signing the Informed Consent Form. The Informed Consent Form was not listed in the report in order to protect the subject's privacy because it was signed by the subject. And it was kept as original information in the clinical trial unit. The clinical trial protocol and informed consent form had been approved by the ethics committee prior to the clinical trial.

Conditions

Renal Failure Chronic

Outcome Measures

Primary Outcomes (3)

• The creatinine clearance rate of hemodiafilter

  Stable dialysis for 60 minutes, with fixed blood flow and dialysate flow under working conditions, set ultrafiltration rate to 10ml/min, and simultaneously draw blood from the dynamic and static pulse ends of the dialyzer to measure creatinine and calculate clearance rate.

  Stable dialysis for 60 minutes±1min

• The urea nitrogen clearance rate of hemodiafilter

  Stable dialysis for 60 minutes, with fixed blood flow and dialysate flow under working conditions, set ultrafiltration rate to 10ml/min, and simultaneously draw blood from the dynamic and static pulse ends of the dialyzer to measure creatinine and calculate clearance rate.

  Stable dialysis for 60 minutes±1min

• β2-MG reduction rate

  When measuring the decline rate, blood is drawn at the beginning and end of hemodialysis filtration, ultrafiltration is stopped, and blood flow is first reduced to 100ml/min. After stopping the pump, blood is immediately drawn from the subject's body.

  blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes

Secondary Outcomes (14)

• Overall blood dialysis filtration creatinine clearance rate

  blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes

• Overall blood dialysis filtration creatinine decrease rate

  blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes

• Overall blood dialysis filtration urea nitrogen clearance rate（Kt/V）

  blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes

• Urea reduction rate（URR）

  blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes

• Ultrafiltration rate

  blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes

Study Arms (2)

EXCLEAR 800

EXPERIMENTAL

"Hemodiafilter" (Model \& spec.: EXCLEAR 800) produced by Shinva Medical Instrument Co.,Ltd.

Device: Hemodiafilter

FX 800HDF

ACTIVE COMPARATOR

Hollow fibre hemodialysis/filter FX 800HDF (registration certificate no.: GuoMeZhiJin 20193101929) manufactured by Fresenius Medical Care AG \& Co.KGaA (Registered agent: Fresenius Medical Care (shanghai) Company Limted)

Device: Fresenius Medical Care AG & Co.KGaA

Interventions

Hemodiafilter DEVICE

The enrolled patients were randomly divided into the experimental group and the control group, using the "hemodiafilter" (experimental device) produced by Shinva Medical Instrument Co.,Ltd.

Also known as: EXCLEAR 800

EXCLEAR 800

Fresenius Medical Care AG & Co.KGaA DEVICE

The enrolled patients were randomly divided into the experimental group and the control group, using the FX 800HDF hollow fiber hemodialysis/filter (control device) produced by Fresenius Medical Care AG \& Co.KGaA (registered agent: Fresenius Medical Care (shanghai) Company Limted).

Also known as: FX 800HDF

FX 800HDF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years, male or female;
• Maintenance dialysis patients with stable chronic renal failure who require hemodiafiltration with a hemodiafilter;
• To maintain a blood flow of 200 ml/min and above during dialysis;
• Patients agreed to participate in this trial and signed an informed consent form.

You may not qualify if:

• Patients who are mental disorder or unstable condition;
• The frequency of dialysis treatment is not satisfied: 2-3 times per week for not less than 4 hours each time, maintained for at least three months;
• Pregnant women, women preparing for pregnancy and lactating;
• Patients with severe anaemia, infection, malignancy, active bleeding;
• Patients with severe cardiac, hepatic and pulmonary diseases;
• Patients with contraindications to dialysis or allergy to any of the components of the hemodiafilter used in this trial;
• Patients who are underweight (dry weight less than 40kg);
• Patients who participated in other clinical trials within 30 days before enrollment that could affect the evaluation of this study;
• Patients who, in the opinion of the investigator, should not be enrolled in this clinical trial.

Sponsors & Collaborators

• Hangzhou Kaiyuan Suixi Medical Technology Co., Ltd: lead

Study Sites (1)

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhangfei Shou

  Zhejiang Provincial Tongde Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 12, 2024
• Study Start: July 23, 2021
• Primary Completion: November 2, 2021
• Study Completion: February 12, 2022
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CN (1)