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NCT Number: NCT02747979

The Effect and Safety of 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hemodialysis only

Other

hemodialysis treatment only

hemodialysis plus hemoperfusion(HA330)

Other

combination of hemodialysis and hemoperfusion (HA330) treatment

hemodialysis plus hemoperfusion(HA130)

Other

combination of hemodialysis and hemoperfusion (HA130) treatment

Primary outcomes

  1. the longitudinal changes of itching

    Time frame: every week, up to 12 weeks.

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 22, 2016
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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