Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02747979
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2015-05-21
Brief Title:
The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Status:
COMPLETED
Status Verified Date:
2016-04
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:
A prospective randomized controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysisHD and hemoperfusionHP on middle molecules removal and complications improvement in long-term maintenance hemodialysis MHD patients
There are two phases of study for each subject Phase 1 screening phase During this phase each potential subject will be evaluated to determine if heshe is eligible for the study
Phase 2 intervention phase Each subject will be randomly allocated to HDHPHA130 once per week group HDHPHA330 once per week group and HD group The follow-up duration was 3 months
There are two phases of study for each subject Phase 1 screening phase During this phase each potential subject will be evaluated to determine if heshe is eligible for the study
Phase 2 intervention phase Each subject will be randomly allocated to HDHPHA130 once per week group HDHPHA330 once per week group and HD group The follow-up duration was 3 months
Detailed Description:
All patients recruited from these centers who met the inclusion criteria were randomly allocated to HDHPHA130 once per week group HDHPHA330 once per week group and HD group The follow-up duration was 3 months
Hemoperfusion is performed by HA130 or HA330 resin adsorbents Blood flow is 200mlmindialysate flow is 500mlmin hemodialysis and hemoperfusion last for 25hcontinue HD after removing the adsorbent to complete 4 hourstreatmentHeparin for anticoagulation first pulse 05-1mgkg appending 8-10mgh Primary endpoint is the improvement of the clinic symptoms meanwhile secondary endpoint is serum β2MGiPTHCRPADMABMP2 decrease compared with the baseline life quality nutrition condition and cardiovascular CVD incidence
Hemoperfusion is performed by HA130 or HA330 resin adsorbents Blood flow is 200mlmindialysate flow is 500mlmin hemodialysis and hemoperfusion last for 25hcontinue HD after removing the adsorbent to complete 4 hourstreatmentHeparin for anticoagulation first pulse 05-1mgkg appending 8-10mgh Primary endpoint is the improvement of the clinic symptoms meanwhile secondary endpoint is serum β2MGiPTHCRPADMABMP2 decrease compared with the baseline life quality nutrition condition and cardiovascular CVD incidence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None