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

Sun Yat-sen University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hyperparathyroidism; Ostalgia; Insomnia; Refractory Pruritus

Treatments: Other: hemodialysis plus hemoperfusion(HA130); Other: hemodialysis plus hemoperfusion(HA330); Other: hemodialysis only

Study type: Interventional

Funder types: Other

Identifiers

NCT02747979

SYSU-HD+HP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

hemodialysis+hemoperfusion (HA330)

Experimental group

Description:

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.

Treatment:

Other: hemodialysis only

Other: hemodialysis plus hemoperfusion(HA330)

hemodialysis+hemoperfusion (HA130)

Experimental group

Description:

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.

Treatment:

Other: hemodialysis plus hemoperfusion(HA130)

Other: hemodialysis only

hemodialysis only

Active Comparator group

Description:

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

Treatment:

Other: hemodialysis only