Clinical Trial for Effectiveness and Safety Evaluation of Hemodiafilter

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

Interventions

DEVICE

Hemodiafilter

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.

DEVICE

Fresenius Medical Care AG & Co.KGaA

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).

Sponsors & Collaborators

• Hangzhou Kaiyuan Suixi Medical Technology Co., Ltd

  lead OTHER

Principal Investigators

• Zhangfei Shou · Zhejiang Provincial Tongde Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-23

Primary Completion

2021-11-02

Completion

2022-02-12

Countries

• China

Study Locations