Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454981
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-05-17
Brief Title:
Clinical Trial for Effectiveness and Safety Evaluation of Hemodiafilter
Sponsor:
Hangzhou Kaiyuan Suixi Medical Technology Co Ltd
Organization:
Hangzhou Kaiyuan Suixi Medical Technology Co Ltd
Study Overview
Official Title:
Clinical Trial for Effectiveness and Safety Evaluation of Hemodiafilter
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical trial was conducted in the nephrology department of Shulan Hang Zhou Hospitalthe 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 CoLtd and the FX 800HDF hollow fiber hemodialysisfilter control device produced by Fresenius Medical Care AG CoKGaA registered agent Fresenius Medical Care shanghai Company Limted respectively To evaluate the effectiveness safety and operability of the hemodiafilter produced by Shinva Medical Instrument CoLtd by means of controlCases 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 subjects 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
The enrolled patients were randomly divided into the experimental group and the control group using the hemodiafilter experimental device produced by Shinva Medical Instrument CoLtd and the FX 800HDF hollow fiber hemodialysisfilter control device produced by Fresenius Medical Care AG CoKGaA registered agent Fresenius Medical Care shanghai Company Limted respectively To evaluate the effectiveness safety and operability of the hemodiafilter produced by Shinva Medical Instrument CoLtd by means of controlCases 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 subjects 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
Detailed Description:
Applicant for Medical Device Registration Shinva Medical Instrument Co Ltd Investigators Zhangfei Shou Chief Physician 01 Center Shulan Hang Zhou HospitalWeixia Huang Chief Physician 02 Center Wenzhou TCM Hospital Jian Huang Chief Physician 03 Center Jinhua Municipal Centeral Hospital Liansheng Liu Chief Physician 04 Center Tongde Hospital of Zhejiang Province Objective Main objective the main objective of this clinical trial is to ensure the safety of the subjects and the scientific validity of the clinical trial in order to evaluate the effectiveness of the experimental medical device hemodiafilter EXCLEAR 800 in patients with chronic renal failure with stable condition compared to the control device hollow fibre hemodialysisfilter FX 800HDF produced by Fresenius Medical Care AG CoKGaA and meet the requirements of China medical device regulations
Secondary objective to evaluate the safety of the experimental medical device hemodiafilter EXCLEAR 800 compared to the control device hollow fibre hemodialysisfilter FX 800HDF manufactured by Fresenius Medical Care AG CoKGaA for hemodiafiltration treatment in patients with stable chronic renal failure
Trial DesignThe 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 a multi-center randomized open positive parallel control non-inferiority designStatistical MethodsGeneral principle
1 Statistical description The quantitative indicators will be described by calculating the mean standard deviation median minimum maximum lower quartile Q1 upper quartile Q3 and the categorical indicators will be described by the number of instances and percentages of each category
2 Statistical Inference For comparisons of the general conditions of the two groups the t-test or Wilcoxon rank-sum test was used to compare the quantitative indicators between groups according to the distribution of data The chi-square test or exact probability method if the chi-square test was not applicable was used for categorical indicators and the Wilcoxon rank-sum test or the CMH test was used for hierarchical data SAS 94 or higher version software was used as the statistical analysis tool for this study and the corresponding statistical analysis methods were selected after discussion with clinical workers and based on the clinical characteristics of different indicators All statistical tests were two-sided unless otherwise stated and a p-value of less than 005 two-sided was considered statistically significant Detailed and additional exploratory analyses may be required in addition to the statistical methods listed below and will be identified in the Study Report and Analysis Plan SAPIn PPS the mean creatinine clearance rate of the main indicator was 18287 in the experimental group and 17596 in the control group with a 95 confidence interval -4532 18348 for the difference between the two groups The lower bound of the confidence interval was greater than the non inferiority threshold The main indicator of urea nitrogen clearance rate is 22660 in the experimental group and 21892 in the control group The 95 confidence interval for the difference between the two groups is -626821624 and the lower bound of the confidence interval is greater than the non inferiority threshold The mean decrease rate of main indicators β2-mg micro globulin in the experimental group was 6487 while the mean in the control group was 6606 The 95 confidence interval for the difference between the two groups was -53092930 and the lower bound of the confidence interval was greater than the non inferiority threshold The main indicators of the experimental group were not inferior to those of the control group
Groups Experimental group Hemodiafilter Model spec EXCLEAR 800 produced by Shinva Medical Instrument CoLtd
Control group Hollow fibre hemodialysisfilter FX 800HDF registration certificate no GuoMeZhiJin 20193101929 manufactured by Fresenius Medical Care AG CoKGaA Registered agent Fresenius Medical Care shanghai Company Limted
Secondary objective to evaluate the safety of the experimental medical device hemodiafilter EXCLEAR 800 compared to the control device hollow fibre hemodialysisfilter FX 800HDF manufactured by Fresenius Medical Care AG CoKGaA for hemodiafiltration treatment in patients with stable chronic renal failure
Trial DesignThe 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 a multi-center randomized open positive parallel control non-inferiority designStatistical MethodsGeneral principle
1 Statistical description The quantitative indicators will be described by calculating the mean standard deviation median minimum maximum lower quartile Q1 upper quartile Q3 and the categorical indicators will be described by the number of instances and percentages of each category
2 Statistical Inference For comparisons of the general conditions of the two groups the t-test or Wilcoxon rank-sum test was used to compare the quantitative indicators between groups according to the distribution of data The chi-square test or exact probability method if the chi-square test was not applicable was used for categorical indicators and the Wilcoxon rank-sum test or the CMH test was used for hierarchical data SAS 94 or higher version software was used as the statistical analysis tool for this study and the corresponding statistical analysis methods were selected after discussion with clinical workers and based on the clinical characteristics of different indicators All statistical tests were two-sided unless otherwise stated and a p-value of less than 005 two-sided was considered statistically significant Detailed and additional exploratory analyses may be required in addition to the statistical methods listed below and will be identified in the Study Report and Analysis Plan SAPIn PPS the mean creatinine clearance rate of the main indicator was 18287 in the experimental group and 17596 in the control group with a 95 confidence interval -4532 18348 for the difference between the two groups The lower bound of the confidence interval was greater than the non inferiority threshold The main indicator of urea nitrogen clearance rate is 22660 in the experimental group and 21892 in the control group The 95 confidence interval for the difference between the two groups is -626821624 and the lower bound of the confidence interval is greater than the non inferiority threshold The mean decrease rate of main indicators β2-mg micro globulin in the experimental group was 6487 while the mean in the control group was 6606 The 95 confidence interval for the difference between the two groups was -53092930 and the lower bound of the confidence interval was greater than the non inferiority threshold The main indicators of the experimental group were not inferior to those of the control group
Groups Experimental group Hemodiafilter Model spec EXCLEAR 800 produced by Shinva Medical Instrument CoLtd
Control group Hollow fibre hemodialysisfilter FX 800HDF registration certificate no GuoMeZhiJin 20193101929 manufactured by Fresenius Medical Care AG CoKGaA Registered agent Fresenius Medical Care shanghai Company Limted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None