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

Overview

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 Title of Study: “The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2010

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: hemodialysis only
    • hemodialysis only All subjects in the study phase will receive regular hemodialysis treatment three times per week.

Clinical Trial Outcome Measures

Primary Measures

  • the longitudinal changes of itching
    • Time Frame: every week, up to 12 weeks.

Secondary Measures

  • the longitudinal changes of serum middle molecules of β2MG concentrations
    • Time Frame: every week,up to 12 weeks.
    • The serum concentration of β2MG will be measured using ELISA method
  • the longitudinal changes of serum middle molecules of iPTH concentrations
    • Time Frame: every week,up to 12 weeks.
    • The serum concentration of iPTH will be measured using ELISA method
  • the longitudinal changes of serum middle molecules of CRP concentrations
    • Time Frame: every week,up to 12 weeks.
    • The serum concentration of CRP will be measured using ELISA method
  • the longitudinal changes of serum middle molecules of ADMA concentrations
    • Time Frame: every week,up to 12 weeks.
    • The serum concentration of ADMA will be measured using ELISA method
  • the longitudinal changes of serum middle molecules of BMP2concentrations
    • Time Frame: every week,up to 12 weeks.
    • The serum concentration of BMP2 will be measured using ELISA method
  • the longitudinal changes of the nutritional status
    • Time Frame: every week,up to 12 weeks.
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xue Qing Yu, Director – Sun Yat-sen University
  • Overall Official(s)
    • Xueqing Yu, MD, Principal Investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
    • Zhihua Zheng, MD, Principal Investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
    • Xunhua Zheng, master, Principal Investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

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