Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639010
• Other study ID #: CHEC2022-207
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Changhai Hospital
• Contact: Zhiyong Guo, professor
• Phone: 18368328998
• Email: drguozhiyong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18-80 years, regardless of gender

2. Stable maintenance hemodialysis for = 3 months with relatively fixed dialysis pattern

3. Hemodialysis treatment 3 times per week, total treatment duration = 10 hours per week, vascular access unlimited

4. Blood ß2-MG > 30 mg/L and/or 300 pg/ml < immunoreactive parathyroid hormone (iPTH) < 800 pg/ml and/or CRP = 16.2 pg/ml

5. Kt/V = 1.2 eight weeks prior to enrollment

6. Signed informed consent form

Exclusion Criteria:

1. Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus

2. 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

3. Blood flow <200 ml/min

4. Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks

5. Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders

6. History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks

7. Cerebral hemorrhage in the last 12 weeks

8. Severe heart failure (New York Heart Association class IV)

9. Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy

10. Pregnancy or breastfeeding

11. Participation in a clinical trial or ongoing clinical trial within 3 months

12. Expected survival of less than 1 year

13. Not considered suitable for participation in this trial by the investigator

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• regular hemodialysis
Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week
• hemoperfusion combined with hemodialysis
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)

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood ß2-microglobulin (ß2-MG) values	Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood ß2-MG in maintenance hemodialysis patients	From date of enrollment until the end of study, assessed up to 52 weeks
Primary	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	From date of enrollment until the end of study, assessed up to 52 weeks
Primary	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	From date of enrollment until the end of study, assessed up to 52 weeks
Secondary	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	From date of enrollment until the end of study, assessed up to 52 weeks
Secondary	Improvement in patients' quality of life	Assessment of quality of life using the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire	From date of enrollment until the end of study, assessed up to 52 weeks
Secondary	Improvement in patients' sleep disturbance	Assessment of sleep disturbance using the Pittsburgh Sleep Quality Index (PSQI)	From date of enrollment until the end of study, assessed up to 52 weeks
Secondary	Improvement in patients' pruritus	Assessment of pruritus using the Duo's pruritus score	From date of enrollment until the end of study, assessed up to 52 weeks