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

April 25, 2016 updated by: Xue Qing Yu, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The 1st Affiliated Hospital, Sun Yet-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: hemodialysis only
hemodialysis treatment only
Other: hemodialysis plus hemoperfusion(HA330)
combination of hemodialysis and hemoperfusion (HA330) treatment
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.
Other: hemodialysis only
hemodialysis treatment only
Other: hemodialysis plus hemoperfusion(HA130)
combination of hemodialysis and hemoperfusion (HA130) treatment
Active Comparator: hemodialysis only
hemodialysis only All subjects in the study phase will receive regular hemodialysis treatment three times per week.
Other: hemodialysis only
hemodialysis treatment only

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every week,up to 12 weeks.
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
every week,up to 12 weeks.
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
every week,up to 12 weeks.
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
every week,up to 12 weeks.
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
every week,up to 12 weeks.
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).
every week,up to 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xueqing Yu, MD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
  • Principal Investigator: Zhihua Zheng, MD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
  • Principal Investigator: Xunhua Zheng, master, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-HD+HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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