NCT02747979

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hyperparathyroidism
• Refractory Pruritus
• Ostalgia
• Insomnia

Interventions

Type	Name	Description
OTHER	hemodialysis only	hemodialysis treatment only
OTHER	hemodialysis plus hemoperfusion(HA330)	combination of hemodialysis and hemoperfusion (HA330) treatment
OTHER	hemodialysis plus hemoperfusion(HA130)	combination of hemodialysis and hemoperfusion (HA130) treatment

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2016-04-22
• Last updated: 2016-04-26

Locations

1 site across 1 country: China