Renal Failure Chronic Clinical Trial
Official title:
Clinical Trial for Effectiveness and Safety Evaluation of Hemodiafilter
Verified date | June 2024 |
Source | Hangzhou Kaiyuan Suixi Medical Technology Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | February 12, 2022 |
Est. primary completion date | November 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Aged 18-80 years, male or female; 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: 1. Patients who are mental disorder or unstable condition; 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. |
Country | Name | City | State |
---|---|---|---|
China | Shulan (Hangzhou) Hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Hangzhou Kaiyuan Suixi Medical Technology Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | ß2-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 | Overall blood dialysis filtration creatinine clearance rate | Ccr=(140?age)×weight(kg)/72×Scr(mg/dl)Ccr=(140?age)×weight(kg)/72×Scr(mg/dl) Or Ccr=[(140?age)×weight(kg)]/[0.818×Scr(umol/L)] Note:Women according to calculation results×0.85 | blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes | |
Secondary | Overall blood dialysis filtration creatinine decrease rate | Overall blood dialysis filtration creatinine decrease rate(%)=1-(Creatinine after hemodialysis filtration/creatinine before hemodialysis filtration)×100% | blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes | |
Secondary | Overall blood dialysis filtration urea nitrogen clearance rate(Kt/V) | Kt/V=-ln(R-0.008×t)+(4-3.5×R ) ×UF/W Formula: Ln:Natural logarithm ; t :Hemodialysis filtration treatment time (h); R :The ratio of BUN after hemodialysis filtration to BUN before hemodialysis filtration; UF:Ultrafiltration capacity (L); W :Patient's weight after blood dialysis filtration (kg). | blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes | |
Secondary | Urea reduction rate(URR) | Urea reduction rate(URR,%)=1-(Blood urea concentration after hemodialysis filtration/blood urea concentration before hemodialysis filtration)×100% | blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes | |
Secondary | Ultrafiltration rate | Ultrafiltration rate (ml/h)=total water removal amount (ml)/treatment time (h) | blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes | |
Secondary | Conduct a blood phosphorus test on the blood of subjects before and after hemodialysis filtration to check if the indicators are qualified. | Qualified: The researcher determined it to be "normal" or "abnormal with no clinical significance".
Unqualified: The researcher determined that the abnormality has clinical significance. |
blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes | |
Secondary | Perform C-reactive protein testing on the blood of subjects before and after hemodialysis filtration to check if the indicators are qualified. | Qualified: The researcher determined it to be "normal" or "abnormal with no clinical significance".
Unqualified: The researcher determined that the abnormality has clinical significance. |
blood is drawn at the beginning within 30 minutes and end of hemodialysis filtration within 30 minutes | |
Secondary | Conduct blood gas (PO2) tests on the blood of subjects before and 15 minutes after the start of hemodialysis filtration to check if the indicators are qualified. | Qualified: The researcher determined it to be "normal" or "abnormal with no clinical significance".
Unqualified: The researcher determined that the abnormality has clinical significance. |
blood is drawn at the beginning within 30 minutes, 15min±1min and end of hemodialysis filtration within 30 minutes | |
Secondary | Conduct blood gas (PCO2) tests on the blood of subjects before and 15 minutes after the start of hemodialysis filtration to check if the indicators are qualified. | Qualified: The researcher determined it to be "normal" or "abnormal with no clinical significance".
Unqualified: The researcher determined that the abnormality has clinical significance. |
blood is drawn at the beginning within 30 minutes, 15min±1min and end of hemodialysis filtration within 30 minutes | |
Secondary | Conduct blood gas (HCO3-) tests on the blood of subjects before and 15 minutes after the start of hemodialysis filtration to check if the indicators are qualified. | Qualified: The researcher determined it to be "normal" or "abnormal with no clinical significance".
Unqualified: The researcher determined that the abnormality has clinical significance. |
blood is drawn at the beginning within 30 minutes, 15min±1min and end of hemodialysis filtration within 30 minutes | |
Secondary | Conduct blood gas (pH) tests on the blood of subjects before and 15 minutes after the start of hemodialysis filtration to check if the indicators are qualified. | Qualified: The researcher determined it to be "normal" or "abnormal with no clinical significance".
Unqualified: The researcher determined that the abnormality has clinical significance. |
blood is drawn at the beginning within 30 minutes, 15min±1min and end of hemodialysis filtration within 30 minutes | |
Secondary | Rupture of membrane | Whether the hemodiafilter breaks the membrane during treatment. Qualified: No membrane rupture occurred in the hemodiafilter during treatment. Unqualified: Membrane rupture of the hemodiafilter occurred during treatment. If the membrane breaks during treatment, the cause and disposal method shall be recorded. | during Hemodialysis filtration period within 4 hours | |
Secondary | transmembrane pressure | During treatment, whether there is a continuous high transmembrane pressure machine alarm, or even can not be used. Qualified: No machine alarm of continuous high transmembrane pressure occurred during treatment.
Unqualified: During treatment, a continuous high transmembrane pressure machine alarm occurred, which could not even be used. If the transmembrane pressure of the hemodiafiltration is persistently high during treatment, the machine will alarm or even fail to use. The reason and disposal method should be recorded. |
during Hemodialysis filtration period within 4 hours | |
Secondary | anticoagulant performance | Hemodiafiltration coagulation degree classification:
Grade 0: No coagulation or coagulation with several fibers. Grade I: Partial or fascicular coagulation. Grade II: Severe coagulation or coagulation of more than half of fibers. Grade III: During hemodiafiltration, the hemodiafiltration device (transmembrane pressure and/or venous pressure) is significantly increased or the hemodiafiltration device needs to be replaced due to membrane rupture and other reasons. Qualified: The coagulation degree of hemodiafiltration was graded as "Grade 0-Grade I". Unqualified: The degree of hemodiafiltration coagulation was graded as "Grade II or above". |
during Hemodialysis filtration period within 4 hours |
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