search
Back to results

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

Primary Purpose

Hyperparathyroidism, Refractory Pruritus, Ostalgia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
hemodialysis only
hemodialysis plus hemoperfusion(HA330)
hemodialysis plus hemoperfusion(HA130)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism focused on measuring hemodialysis, hyperparathyroidism, refractory pruritus, ostalgia, insomnia, CVD incidence, life quality

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The 1st Affiliated Hospital, Sun Yet-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

hemodialysis+hemoperfusion (HA330)

hemodialysis+hemoperfusion (HA130)

hemodialysis only

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

the longitudinal changes of itching

Secondary Outcome Measures

the longitudinal changes of serum middle molecules of β2MG concentrations
The serum concentration of β2MG will be measured using ELISA method
the longitudinal changes of serum middle molecules of iPTH concentrations
The serum concentration of iPTH will be measured using ELISA method
the longitudinal changes of serum middle molecules of CRP concentrations
The serum concentration of CRP will be measured using ELISA method
the longitudinal changes of serum middle molecules of ADMA concentrations
The serum concentration of ADMA will be measured using ELISA method
the longitudinal changes of serum middle molecules of BMP2concentrations
The serum concentration of BMP2 will be measured using ELISA method
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).

Full Information

First Posted
May 21, 2015
Last Updated
April 25, 2016
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT02747979
Brief Title
The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Official Title
The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Refractory Pruritus, Ostalgia, Insomnia
Keywords
hemodialysis, hyperparathyroidism, refractory pruritus, ostalgia, insomnia, CVD incidence, life quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hemodialysis+hemoperfusion (HA330)
Arm Type
Experimental
Arm 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.
Arm Title
hemodialysis+hemoperfusion (HA130)
Arm Type
Experimental
Arm 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.
Arm Title
hemodialysis only
Arm Type
Active Comparator
Arm Description
hemodialysis only All subjects in the study phase will receive regular hemodialysis treatment three times per week.
Intervention Type
Other
Intervention Name(s)
hemodialysis only
Intervention Description
hemodialysis treatment only
Intervention Type
Other
Intervention Name(s)
hemodialysis plus hemoperfusion(HA330)
Intervention Description
combination of hemodialysis and hemoperfusion (HA330) treatment
Intervention Type
Other
Intervention Name(s)
hemodialysis plus hemoperfusion(HA130)
Intervention Description
combination of hemodialysis and hemoperfusion (HA130) treatment
Primary Outcome Measure Information:
Title
the longitudinal changes of itching
Time Frame
every week, up to 12 weeks.
Secondary Outcome Measure Information:
Title
the longitudinal changes of serum middle molecules of β2MG concentrations
Description
The serum concentration of β2MG will be measured using ELISA method
Time Frame
every week,up to 12 weeks.
Title
the longitudinal changes of serum middle molecules of iPTH concentrations
Description
The serum concentration of iPTH will be measured using ELISA method
Time Frame
every week,up to 12 weeks.
Title
the longitudinal changes of serum middle molecules of CRP concentrations
Description
The serum concentration of CRP will be measured using ELISA method
Time Frame
every week,up to 12 weeks.
Title
the longitudinal changes of serum middle molecules of ADMA concentrations
Description
The serum concentration of ADMA will be measured using ELISA method
Time Frame
every week,up to 12 weeks.
Title
the longitudinal changes of serum middle molecules of BMP2concentrations
Description
The serum concentration of BMP2 will be measured using ELISA method
Time Frame
every week,up to 12 weeks.
Title
the longitudinal changes of the nutritional status
Description
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).
Time Frame
every week,up to 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueqing Yu, MD
Organizational Affiliation
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhihua Zheng, MD
Organizational Affiliation
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xunhua Zheng, master
Organizational Affiliation
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Affiliated Hospital, Sun Yet-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33283264
Citation
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs