Clinical Trial for Effectiveness and Safety Evaluation of Hemodiafilter
NCT ID: NCT06454981
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
160 participants
INTERVENTIONAL
2021-07-23
2022-02-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
NCT05698420
A Comparative Study of Two Kinds of Hemodialysis Filters
NCT05899283
Multi-center Clinical Study on Hemoperfusion of KHA80
NCT06233838
High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
NCT03456232
Clinical Evaluation of the CM-1500 During Hemodialysis
NCT05125848
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary objective: to evaluate the safety of the experimental medical device hemodiafilter (EXCLEAR 800) compared to the control device hollow fibre hemodialysis/filter (FX 800HDF) manufactured by Fresenius Medical Care AG \& Co.KGaA for hemodiafiltration treatment in patients with stable chronic renal failure.
Trial Design: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 a multi-center, randomized, open, positive parallel control, non-inferiority design.Statistical Methods:General 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 9.4 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 0.05 (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 (SAP).In PPS, the mean creatinine clearance rate of the main indicator was 182.87 in the experimental group and 175.96 in the control group, with a 95% confidence interval \[-4.532, 18.348\] 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 226.60 in the experimental group and 218.92 in the control group. The 95% confidence interval for the difference between the two groups is \[-6.268,21.624\], 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 64.87%, while the mean in the control group was 66.06%. The 95% confidence interval for the difference between the two groups was \[-5.309,2.930\], 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 Co.,Ltd.
Control group: 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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EXCLEAR 800
"Hemodiafilter" (Model \& spec.: EXCLEAR 800) produced by Shinva Medical Instrument Co.,Ltd.
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.
FX 800HDF
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)
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Maintenance dialysis patients with stable chronic renal failure who require hemodiafiltration with a hemodiafilter;
3. To maintain a blood flow of 200 ml/min and above during dialysis;
4. Patients agreed to participate in this trial and signed an informed consent form.
Exclusion Criteria
2. 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;
3. Pregnant women, women preparing for pregnancy and lactating;
4. Patients with severe anaemia, infection, malignancy, active bleeding;
5. Patients with severe cardiac, hepatic and pulmonary diseases;
6. Patients with contraindications to dialysis or allergy to any of the components of the hemodiafilter used in this trial;
7. Patients who are underweight (dry weight less than 40kg);
8. Patients who participated in other clinical trials within 30 days before enrollment that could affect the evaluation of this study;
9. Patients who, in the opinion of the investigator, should not be enrolled in this clinical trial.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hangzhou Kaiyuan Suixi Medical Technology Co., Ltd
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhangfei Shou
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial Tongde Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XH202101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.