Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05639010
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2022-11-06
Brief Title:
Benefits of Hemodialysis Plus Hemoperfusion A Clinical Study
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
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:
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 HDHP 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 timesweek the experimental group 205 patients will be treated with Jafron KHA80 hemoperfusion apparatus in addition to hemodialysis or hemofiltration with a frequency of 1 timeweek 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 liverkidney function coagulation system tests etc chest X-ray electrocardiogram and cardiac ultrasound Dialysis adequacy as defined by standard KtV 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 eg 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 Duos pruritus score
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