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Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study

Primary Purpose

End Stage Renal Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
regular hemodialysis
hemoperfusion combined with hemodialysis
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80 years, regardless of gender Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited Blood β2-MG > 30 mg/L and/or 300 pg/ml < immunoreactive parathyroid hormone (iPTH) < 800 pg/ml and/or CRP ≥ 16.2 pg/ml Kt/V ≥ 1.2 eight weeks prior to enrollment Signed informed consent form Exclusion Criteria: Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus Test indicators meeting one or more of the following: white blood cell <4 x 10^9/L, platelet count <60 x 10^9/L, serum albumin <30 g/L Blood flow <200 ml/min Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks Cerebral hemorrhage in the last 12 weeks Severe heart failure (New York Heart Association class IV) Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy Pregnancy or breastfeeding Participation in a clinical trial or ongoing clinical trial within 3 months Expected survival of less than 1 year Not considered suitable for participation in this trial by the investigator

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

regular hemodialysis

hemoperfusion combined with hemodialysis

Arm Description

Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week

Routine blood purification therapy 3 times a week + Combination of hemodialysis and hemoperfusion treatment once a week

Outcomes

Primary Outcome Measures

Changes in blood β2-microglobulin (β2-MG) values
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood β2-MG in maintenance hemodialysis patients
Changes in blood Parathyroid Hormone (PTH) values
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood PTH in maintenance hemodialysis patients
Changes in blood C Reactive Protein (CRP) values
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood CRP in maintenance hemodialysis patients

Secondary Outcome Measures

Change in serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) values
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) in maintenance hemodialysis patients
Improvement in patients' quality of life
Assessment of quality of life using the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire
Improvement in patients' sleep disturbance
Assessment of sleep disturbance using the Pittsburgh Sleep Quality Index (PSQI)
Improvement in patients' pruritus
Assessment of pruritus using the Duo's pruritus score

Full Information

First Posted
November 6, 2022
Last Updated
February 1, 2023
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05639010
Brief Title
Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study
Official Title
A Multi-center, Open-label, Randomized Trial of Hemodialysis Plus Hemoperfusion on Blood β2-microglobulin (β2-MG), Parathyroid Hormone (PTH) and C Reactive Protein (CRP) Clearance in Maintenance Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This multi-center, open-label, randomized, parallel controlled trial aims to investigate the efficacy of hemoperfusion (HP) in combination with hemodialysis (HD) by assessing blood β2-microglobulin (β2-MG), parathyroid hormone (PTH) and C reactive protein (CRP) clearance in maintenance hemodialysis patients.
Detailed Description
In this HD/HP vs HD trial, the investigators plan to enroll 410 maintenance hemodialysis patients. Twelve medical centers in the Shanghai metropolitan area have expressed interest in participating. Participants will be randomized into 2 groups after a 1-month washout period. The control group (205 patients) will be treated with hemodialysis or hemofiltration with a frequency of 3 times/week; the experimental group (205 patients) will be treated with Jafron KHA80 hemoperfusion apparatus in addition to hemodialysis or hemofiltration with a frequency of 1 time/week. Follow-up data before the last dialysis at 4, 12, 24, 36 and 52 weeks of treatment were collected from both groups, including the following: routine physical examination, laboratory tests (blood routine, blood biochemistry, β2-MG, PTH, CRP, liver/kidney function, coagulation system tests, etc.), chest X-ray, electrocardiogram and cardiac ultrasound. Dialysis adequacy as defined by standard Kt/V will be calculated. Comorbidities, combined medications and adverse events will also be captured. The primary outcomes will include change in blood β2-MG, PTH and CRP values. Secondary outcomes will include change values for serum protein-bound toxins (e.g., p-Cresol sulfate, indophenol sulphate), improvement in patient quality of life (Kidney Disease Quality of Life Short Form), sleep disturbance (Pittsburgh Sleep Quality Index) and pruritus (Duo's pruritus score).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
regular hemodialysis
Arm Type
Active Comparator
Arm Description
Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week
Arm Title
hemoperfusion combined with hemodialysis
Arm Type
Experimental
Arm Description
Routine blood purification therapy 3 times a week + Combination of hemodialysis and hemoperfusion treatment once a week
Intervention Type
Device
Intervention Name(s)
regular hemodialysis
Intervention Description
Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week
Intervention Type
Device
Intervention Name(s)
hemoperfusion combined with hemodialysis
Intervention Description
Hemoperfusion combined with hemodialysis treatment will perform once a week. The hemoperfusion apparatus will use type KHA80 hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)
Primary Outcome Measure Information:
Title
Changes in blood β2-microglobulin (β2-MG) values
Description
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood β2-MG in maintenance hemodialysis patients
Time Frame
From date of enrollment until the end of study, assessed up to 52 weeks
Title
Changes in blood Parathyroid Hormone (PTH) values
Description
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood PTH in maintenance hemodialysis patients
Time Frame
From date of enrollment until the end of study, assessed up to 52 weeks
Title
Changes in blood C Reactive Protein (CRP) values
Description
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood CRP in maintenance hemodialysis patients
Time Frame
From date of enrollment until the end of study, assessed up to 52 weeks
Secondary Outcome Measure Information:
Title
Change in serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) values
Description
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) in maintenance hemodialysis patients
Time Frame
From date of enrollment until the end of study, assessed up to 52 weeks
Title
Improvement in patients' quality of life
Description
Assessment of quality of life using the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire
Time Frame
From date of enrollment until the end of study, assessed up to 52 weeks
Title
Improvement in patients' sleep disturbance
Description
Assessment of sleep disturbance using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
From date of enrollment until the end of study, assessed up to 52 weeks
Title
Improvement in patients' pruritus
Description
Assessment of pruritus using the Duo's pruritus score
Time Frame
From date of enrollment until the end of study, assessed up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years, regardless of gender Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited Blood β2-MG > 30 mg/L and/or 300 pg/ml < immunoreactive parathyroid hormone (iPTH) < 800 pg/ml and/or CRP ≥ 16.2 pg/ml Kt/V ≥ 1.2 eight weeks prior to enrollment Signed informed consent form Exclusion Criteria: Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus Test indicators meeting one or more of the following: white blood cell <4 x 10^9/L, platelet count <60 x 10^9/L, serum albumin <30 g/L Blood flow <200 ml/min Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks Cerebral hemorrhage in the last 12 weeks Severe heart failure (New York Heart Association class IV) Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy Pregnancy or breastfeeding Participation in a clinical trial or ongoing clinical trial within 3 months Expected survival of less than 1 year Not considered suitable for participation in this trial by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyong Guo, professor
Phone
18368328998
Email
drguozhiyong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiyong Guo, professor
Organizational Affiliation
Changhai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong Guo, professor
Phone
18368328998
Email
drguozhiyong@163.com

12. IPD Sharing Statement

Learn more about this trial

Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study

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