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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02747979
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

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.


Condition or disease Intervention/treatment Phase
Hyperparathyroidism Refractory Pruritus Ostalgia Insomnia Other: hemodialysis only Other: hemodialysis plus hemoperfusion(HA330) Other: hemodialysis plus hemoperfusion(HA130) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Study Start Date : April 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching

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




Primary Outcome Measures :
  1. the longitudinal changes of itching [ Time Frame: every week, up to 12 weeks. ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747979


Locations
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China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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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

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Responsible Party: Xue Qing Yu, Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02747979    
Other Study ID Numbers: SYSU-HD+HP
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Keywords provided by Xue Qing Yu, Sun Yat-sen University:
hemodialysis
hyperparathyroidism
refractory pruritus
ostalgia
insomnia
CVD incidence
life quality
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Pruritus
Hyperparathyroidism
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Parathyroid Diseases
Endocrine System Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms