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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747979
• Other study ID #: SYSU-HD+HP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 21, 2015
• Last updated: April 25, 2016
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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, ß2MG>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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Insomnia
• Ostalgia
• Pruritus
• Refractory Pruritus

Intervention

Other:
• hemodialysis only
hemodialysis treatment only
• hemodialysis plus hemoperfusion(HA330)
combination of hemodialysis and hemoperfusion (HA330) treatment
• hemodialysis plus hemoperfusion(HA130)
combination of hemodialysis and hemoperfusion (HA130) treatment

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the longitudinal changes of itching		every week, up to 12 weeks.	Yes
Secondary	the longitudinal changes of serum middle molecules of ß2MG concentrations	The serum concentration of ß2MG will be measured using ELISA method	every week,up to 12 weeks.	Yes
Secondary	the longitudinal changes of serum middle molecules of iPTH concentrations	The serum concentration of iPTH will be measured using ELISA method	every week,up to 12 weeks.	Yes
Secondary	the longitudinal changes of serum middle molecules of CRP concentrations	The serum concentration of CRP will be measured using ELISA method	every week,up to 12 weeks.	Yes
Secondary	the longitudinal changes of serum middle molecules of ADMA concentrations	The serum concentration of ADMA will be measured using ELISA method	every week,up to 12 weeks.	Yes
Secondary	the longitudinal changes of serum middle molecules of BMP2concentrations	The serum concentration of BMP2 will be measured using ELISA method	every week,up to 12 weeks.	Yes
Secondary	the longitudinal changes of the nutritional status	The nutritional status was evaluated using the serum level of albumin, the subjective global assessment score and BMI. The serum level of albumin will measured using the blood analysis biochemical analyzer, the subjective global assessment score will measured using the SGA scale and the BMI will measured through the physical examination and calculated by weight (kg)/height2 (m2).	every week,up to 12 weeks.	Yes