The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-05-31

Brief Summary

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A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) 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 he/she is eligible for the study.

Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.

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Detailed Description

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All patients recruited from these centers who met the inclusion criteria were randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 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 200ml/min，dialysate flow is 500ml/min， hemodialysis and hemoperfusion last for 2.5h，continue HD after removing the adsorbent to complete 4 hours'treatment.Heparin for anticoagulation ：first pulse 0.5-1mg/kg ，appending 8-10mg/h. Primary endpoint is the improvement of the clinic symptoms, meanwhile secondary endpoint is serum β2MG、iPTH、CRP、ADMA、BMP2 decrease compared with the baseline, life quality, nutrition condition, and cardiovascular (CVD) incidence.

Conditions

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Hyperparathyroidism Refractory Pruritus Ostalgia Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hemodialysis+hemoperfusion (HA330)

Combination of hemodialysis and hemoperfusion (HA330) therapy All subjects in the study phase will receive hemodialysis plus hemoperfusion(HA330) treatment once per week, and regular hemodialysis treatment in the remaining two sessions.

Group Type EXPERIMENTAL

hemodialysis only

Intervention Type OTHER

hemodialysis treatment only

hemodialysis plus hemoperfusion(HA330)

Intervention Type OTHER

combination of hemodialysis and hemoperfusion (HA330) treatment

hemodialysis+hemoperfusion (HA130)

Combination of hemodialysis and hemoperfusion (HA130) treatment All subjects in the study phase will receive hemodialysis and hemoperfusion(HA130) treatment once per week, and regular hemodialysis treatment in the remaining two sessions.

Group Type EXPERIMENTAL

hemodialysis only

Intervention Type OTHER

hemodialysis treatment only

hemodialysis plus hemoperfusion(HA130)

Intervention Type OTHER

combination of hemodialysis and hemoperfusion (HA130) treatment

hemodialysis only

hemodialysis only All subjects in the study phase will receive regular hemodialysis treatment three times per week.

Group Type ACTIVE_COMPARATOR

hemodialysis only

Intervention Type OTHER

hemodialysis treatment only

Interventions

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hemodialysis only

hemodialysis treatment only

Intervention Type OTHER

hemodialysis plus hemoperfusion(HA330)

combination of hemodialysis and hemoperfusion (HA330) treatment

Intervention Type OTHER

hemodialysis plus hemoperfusion(HA130)

combination of hemodialysis and hemoperfusion (HA130) treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willingness to sign an informed consent
* Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
* middle or large molecules retention defined as immunoreactive parathyroid hormone (iPTH) \> 400 pg/mL, β2MG\>5000 pg/ml、CRP\>10mg/l.
* Refractory pruritus, carpal tunnel syndrome, restless leg syndrome, hyperparathyroidism or other refratory complications.

Exclusion Criteria

* Incapable or reluctant to sign the informed consent or comply the schedule.
* platelet (PLT) count\<60×109/L or disturbance in coagulation, tendency of severe bleeding or acute bleeding.
* Severe hypotension and heart or lung insufficiency
* Known hypersensitive or contradiction or intolerance to dialyzer or adsorbents
* Attend to other clinic trial now or in recent 30 days

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No